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Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00416455
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : December 14, 2015
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Stage I Endometrial Carcinoma
Stage IB Cervical Cancer
Stage II Endometrial Carcinoma
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Endometrial Carcinoma
Stage IVA Cervical Cancer
Interventions Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: computed tomography
Drug: ferumoxtran-10
Procedure: magnetic resonance imaging
Procedure: diagnostic lymphadenectomy
Procedure: lymph node biopsy
Enrollment 384

Recruitment Details The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 (NCT 00416455) closed to accrual on 6/21/2013.
Pre-assignment Details  
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Period Title: Overall Study
Started 169 [1] 215 [1]
Completed 153 [2] 207 [2]
Not Completed 16 8
Reason Not Completed
PET / CT not done             3             5
PET / CT poor quality             2             1
Inadequate pathology             11             2
[1]
This is a diagnostic imaging study.
[2]
Number of patients with adequate imaging and pathology
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients Total
Hide Arm/Group Description PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan Total of all reporting groups
Overall Number of Baseline Participants 153 207 360
Hide Baseline Analysis Population Description
Adequate imaging and pathologically eligible patients (N =360)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 207 participants 360 participants
49  (11.6) 64.8  (9.9) 58  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 207 participants 360 participants
Female
153
 100.0%
207
 100.0%
360
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Time Frame Before surgery (FDG-PET-CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
50
(44 to 56)
65
(57 to 72)
2.Primary Outcome
Title The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(80 to 89)
88
(83 to 92)
3.Secondary Outcome
Title The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
Time Frame Before surgery (DCT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
83
(78 to 87)
65
(57 to 72)
4.Secondary Outcome
Title The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
63
(54 to 70)
93
(86 to 96)
5.Secondary Outcome
Title The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients.
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
81
(77 to 85)
63
(56 to 70)
6.Secondary Outcome
Title The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients.
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
69
(59 to 77)
83
(76 to 88)
7.Secondary Outcome
Title Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients - Sensitivity of CT Endometrial Cancer Cohort - Sensitivity of CT
Hide Arm/Group Description:
CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients.
CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
42
(36 to 48)
50
(43 to 58)
8.Secondary Outcome
Title Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients - Sensitivity of CT Endometrial Cancer Cohort - Sensitivity of CT
Hide Arm/Group Description:
CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
79
(73 to 83)
48
(41 to 56)
9.Secondary Outcome
Title Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Hide Description The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients-Sensitivity of CT Endometrial Cancer Patients
Hide Arm/Group Description:
CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after CT scan
CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
77
(73 to 81)
54
(47 to 61)
10.Secondary Outcome
Title Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
89
(84 to 92)
93
(89 to 96)
11.Secondary Outcome
Title Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
62
(53 to 69)
89
(82 to 94)
12.Secondary Outcome
Title Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
Hide Description The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
63
(54 to 72)
85
(78 to 90)
13.Secondary Outcome
Title Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Hide Description [Not Specified]
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Measure Type: Number
Unit of Measure: percentage of participants
9 10
14.Secondary Outcome
Title Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Hide Description [Not Specified]
Time Frame Before surgery (FDG-PET/CT) and after surgery (pathology)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description:
PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
Overall Number of Participants Analyzed 80 49
Measure Type: Number
Unit of Measure: percentage of participants
10 6
15.Secondary Outcome
Title Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Hide Description Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Time Frame During surgery and up to 30 days after surgery.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy
Arm/Group Title Number of Participants With a Maximum Grade of 3 or Higher Dur
Hide Arm/Group Description:
Number of participants with a maximum grade of 3 or higher during treatment period and up to 30 days after stopping study treatment.
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia 1
Thrombocytopenia 1
Anemia 7
Other Hematologic 1
Dermatologic 1
Gastrointestinal 4
Infection 9
Lymphatics 5
Metabolic 3
Musculoskeletal 1
Pain 2
Vascular 3
16.Secondary Outcome
Title Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Hide Description Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Time Frame Within 4 weeks from PET/CT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation
Arm/Group Title Cause of Delay in the Initiation of Chemo-radiation Therapy mo
Hide Arm/Group Description:
All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced a delay in the initiation of chemo-radiation therapy
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
Surgery related adverse events
3
   2.4%
Patient preference/scheduling difficulty
21
  16.5%
Other
6
   4.7%
Not reported
3
   2.4%
No Delay
94
  74.0%
17.Secondary Outcome
Title Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Hide Description Number of cervical cancer patients with reasons of interruption in radiation therapy
Time Frame Within 6 weeks after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy
Arm/Group Title Causes of Interruption in Radiation Therapy
Hide Arm/Group Description:
Number of participants with reasons of interruption in radiation therapy
Overall Number of Participants Analyzed 127
Measure Type: Count of Participants
Unit of Measure: Participants
Chemoradiation related adverse events
1
   0.8%
Patient preference/scheduling difficulty
1
   0.8%
Other
9
   7.1%
Not reported
14
  11.0%
No interruption
102
  80.3%
Time Frame All Adverse Events (AEs) occurring within 30 days of surgery are reported
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervical Cancer Patients Endometrial Cancer Patients
Hide Arm/Group Description PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
All-Cause Mortality
Cervical Cancer Patients Endometrial Cancer Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervical Cancer Patients Endometrial Cancer Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   17/169 (10.06%)   19/215 (8.84%) 
Blood and lymphatic system disorders     
Lymphocele * 1  0/169 (0.00%)  1/215 (0.47%) 
Cardiac disorders     
Conduction Abnml: Asystole * 1  0/169 (0.00%)  1/215 (0.47%) 
S/N Arrhythmia: Atrial Flutter * 1  0/169 (0.00%)  1/215 (0.47%) 
Hypotension * 1  1/169 (0.59%)  0/215 (0.00%) 
Gastrointestinal disorders     
Fistula, Gi - Colon/Cecum/Appendix * 1  1/169 (0.59%)  0/215 (0.00%) 
Obstruction, Gi - Colon * 1  1/169 (0.59%)  0/215 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  0/169 (0.00%)  3/215 (1.40%) 
Dehydration * 1  0/169 (0.00%)  1/215 (0.47%) 
Nausea * 1  0/169 (0.00%)  1/215 (0.47%) 
General disorders     
Death No Ctcae Term - Death Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Pain: Gallbladder * 1  1/169 (0.59%)  0/215 (0.00%) 
Pain: Abdominal Pain Nos * 1  1/169 (0.59%)  0/215 (0.00%) 
Tumor Flare * 1  1/169 (0.59%)  0/215 (0.00%) 
Infections and infestations     
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  2/169 (1.18%)  0/215 (0.00%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/169 (0.00%)  1/215 (0.47%) 
Infection - Other * 1  1/169 (0.59%)  0/215 (0.00%) 
Inf Unknown Anc: Pelvis Nos * 1  1/169 (0.59%)  1/215 (0.47%) 
Inf Unknown Anc: Lymphatic * 1  1/169 (0.59%)  0/215 (0.00%) 
Inf Unknown Anc: Small Bowel Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Inf Unknown Anc: Abdomen Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  1/169 (0.59%)  0/215 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
2nd Mal: Poss. Related To Cancer Rx * 1  1/169 (0.59%)  0/215 (0.00%) 
Renal and urinary disorders     
Leak, Gu - Ureter * 1  0/169 (0.00%)  1/215 (0.47%) 
Surgical and medical procedures     
Intra-Op Injury: Other * 1  0/169 (0.00%)  1/215 (0.47%) 
Vascular disorders     
Hemorrhage, Gu - Vagina * 1  0/169 (0.00%)  1/215 (0.47%) 
Hemorrhage With Surgery * 1  0/169 (0.00%)  1/215 (0.47%) 
Hemorrhage, Gi - Abdomen Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Hemorrhage/Bleeding - Other * 1  1/169 (0.59%)  0/215 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  1/169 (0.59%)  0/215 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  2/169 (1.18%)  1/215 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cervical Cancer Patients Endometrial Cancer Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   108/169 (63.91%)   132/215 (61.40%) 
Blood and lymphatic system disorders     
Neutrophils * 1  6/169 (3.55%)  6/215 (2.79%) 
Platelets * 1  19/169 (11.24%)  11/215 (5.12%) 
Blood/Bone Marrow - Other * 1  3/169 (1.78%)  3/215 (1.40%) 
Leukocytes * 1  24/169 (14.20%)  13/215 (6.05%) 
Lymphopenia * 1  2/169 (1.18%)  2/215 (0.93%) 
Hemoglobin * 1  80/169 (47.34%)  88/215 (40.93%) 
Lymphatics - Other * 1  1/169 (0.59%)  0/215 (0.00%) 
Lymphocele * 1  6/169 (3.55%)  1/215 (0.47%) 
Edema: Viscera * 1  1/169 (0.59%)  0/215 (0.00%) 
Edema: Trunk/Genital * 1  2/169 (1.18%)  0/215 (0.00%) 
Edema: Limb * 1  3/169 (1.78%)  5/215 (2.33%) 
Chyle Or Lymph Leakage * 1  0/169 (0.00%)  2/215 (0.93%) 
Cardiac disorders     
S/N Arrhythmia: Atrial Fibrillation * 1  0/169 (0.00%)  1/215 (0.47%) 
Palpitations * 1  1/169 (0.59%)  1/215 (0.47%) 
Conduction Abnml: Asystole * 1  0/169 (0.00%)  1/215 (0.47%) 
S/N Arrhythmia: Atrial Flutter * 1  0/169 (0.00%)  1/215 (0.47%) 
S/N Arrhythmia: Sinus Tachycardia * 1  1/169 (0.59%)  1/215 (0.47%) 
S/N Arrhythmia: Sinus Bradycardia * 1  0/169 (0.00%)  1/215 (0.47%) 
Hypertension * 1  0/169 (0.00%)  1/215 (0.47%) 
Hypotension * 1  3/169 (1.78%)  2/215 (0.93%) 
Endocrine disorders     
Hot Flashes * 1  0/169 (0.00%)  1/215 (0.47%) 
Gastrointestinal disorders     
Fistula, Gi - Colon/Cecum/Appendix * 1  1/169 (0.59%)  0/215 (0.00%) 
Flatulence * 1  3/169 (1.78%)  1/215 (0.47%) 
Hemorrhoids * 1  0/169 (0.00%)  1/215 (0.47%) 
Heartburn * 1  1/169 (0.59%)  0/215 (0.00%) 
Leak, Gi - Leak Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Fistula, Gi - Jejunum * 1  1/169 (0.59%)  0/215 (0.00%) 
Ileus * 1  2/169 (1.18%)  7/215 (3.26%) 
Distention * 1  1/169 (0.59%)  0/215 (0.00%) 
Dry Mouth * 1  1/169 (0.59%)  0/215 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  2/169 (1.18%)  2/215 (0.93%) 
Colitis * 1  1/169 (0.59%)  0/215 (0.00%) 
Obstruction, Gi - Jejunum * 1  1/169 (0.59%)  0/215 (0.00%) 
Vomiting * 1  8/169 (4.73%)  7/215 (3.26%) 
Anorexia * 1  9/169 (5.33%)  8/215 (3.72%) 
Dehydration * 1  3/169 (1.78%)  2/215 (0.93%) 
Constipation * 1  12/169 (7.10%)  10/215 (4.65%) 
Nausea * 1  18/169 (10.65%)  12/215 (5.58%) 
Gastrointestinal - Other * 1  0/169 (0.00%)  2/215 (0.93%) 
Diarrhea * 1  6/169 (3.55%)  4/215 (1.86%) 
General disorders     
Weight Gain * 1  1/169 (0.59%)  0/215 (0.00%) 
Fever * 1  6/169 (3.55%)  4/215 (1.86%) 
Weight Loss * 1  2/169 (1.18%)  1/215 (0.47%) 
Rigors/Chills * 1  2/169 (1.18%)  0/215 (0.00%) 
Fatigue * 1  7/169 (4.14%)  11/215 (5.12%) 
Insomnia * 1  0/169 (0.00%)  1/215 (0.47%) 
Death No Ctcae Term - Disease Progression Nos * 1  1/169 (0.59%)  0/215 (0.00%) 
Death No Ctcae Term - Death Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Pain - Other * 1  3/169 (1.78%)  3/215 (1.40%) 
Pain: Urethra * 1  2/169 (1.18%)  0/215 (0.00%) 
Pain: Pelvis * 1  5/169 (2.96%)  0/215 (0.00%) 
Pain: Breast * 1  1/169 (0.59%)  0/215 (0.00%) 
Pain: Vagina * 1  1/169 (0.59%)  0/215 (0.00%) 
Pain: Chest /Thorax Nos * 1  1/169 (0.59%)  1/215 (0.47%) 
Pain: Chest Wall * 1  0/169 (0.00%)  1/215 (0.47%) 
Pain: Head/Headache * 1  4/169 (2.37%)  0/215 (0.00%) 
Pain: Extremity-Limb * 1  4/169 (2.37%)  2/215 (0.93%) 
Pain: Back * 1  4/169 (2.37%)  2/215 (0.93%) 
Pain: Joint * 1  0/169 (0.00%)  1/215 (0.47%) 
Pain: Gallbladder * 1  1/169 (0.59%)  0/215 (0.00%) 
Pain: Abdominal Pain Nos * 1  12/169 (7.10%)  14/215 (6.51%) 
Pain: Skin * 1  1/169 (0.59%)  0/215 (0.00%) 
Pain: Muscle * 1  0/169 (0.00%)  1/215 (0.47%) 
Pain: Anus * 1  1/169 (0.59%)  0/215 (0.00%) 
Flu-Like Syndrome * 1  0/169 (0.00%)  1/215 (0.47%) 
Infections and infestations     
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  0/169 (0.00%)  3/215 (1.40%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  3/169 (1.78%)  0/215 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  1/169 (0.59%)  0/215 (0.00%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/169 (0.00%)  2/215 (0.93%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  0/169 (0.00%)  1/215 (0.47%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  4/169 (2.37%)  1/215 (0.47%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  1/169 (0.59%)  0/215 (0.00%) 
Infection - Other * 1  0/169 (0.00%)  1/215 (0.47%) 
Colitis, Infectious (Eg.C. Difficile) * 1  1/169 (0.59%)  1/215 (0.47%) 
Inf Unknown Anc: Pelvis Nos * 1  1/169 (0.59%)  1/215 (0.47%) 
Inf Unknown Anc: Upper Airway Nos * 1  1/169 (0.59%)  0/215 (0.00%) 
Inf Unknown Anc: Bronchus * 1  0/169 (0.00%)  1/215 (0.47%) 
Inf Unknown Anc: Urinary Tract Nos * 1  2/169 (1.18%)  3/215 (1.40%) 
Inf Unknown Anc: Wound * 1  1/169 (0.59%)  1/215 (0.47%) 
Inf Unknown Anc: Abdomen Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  1/169 (0.59%)  2/215 (0.93%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  0/169 (0.00%)  1/215 (0.47%) 
Metabolism and nutrition disorders     
Ast * 1  1/169 (0.59%)  3/215 (1.40%) 
Metabolic/Laboratory - Other * 1  2/169 (1.18%)  1/215 (0.47%) 
Proteinuria * 1  0/169 (0.00%)  1/215 (0.47%) 
Hemoglobinuria * 1  0/169 (0.00%)  1/215 (0.47%) 
Creatinine * 1  2/169 (1.18%)  9/215 (4.19%) 
Hypoalbuminemia * 1  5/169 (2.96%)  19/215 (8.84%) 
Alt * 1  3/169 (1.78%)  4/215 (1.86%) 
Alkaline Phosphatase * 1  1/169 (0.59%)  7/215 (3.26%) 
Hypermagnesemia * 1  2/169 (1.18%)  2/215 (0.93%) 
Hypophosphatemia * 1  1/169 (0.59%)  7/215 (3.26%) 
Hyponatremia * 1  7/169 (4.14%)  18/215 (8.37%) 
Hypernatremia * 1  1/169 (0.59%)  0/215 (0.00%) 
Hypocalcemia * 1  15/169 (8.88%)  52/215 (24.19%) 
Hyperkalemia * 1  1/169 (0.59%)  5/215 (2.33%) 
Hyperglycemia * 1  14/169 (8.28%)  51/215 (23.72%) 
Hypokalemia * 1  9/169 (5.33%)  27/215 (12.56%) 
Hypoglycemia * 1  0/169 (0.00%)  1/215 (0.47%) 
Hypercalcemia * 1  1/169 (0.59%)  3/215 (1.40%) 
Hypomagnesemia * 1  4/169 (2.37%)  9/215 (4.19%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal/St: Other * 1  0/169 (0.00%)  1/215 (0.47%) 
Soft Tissue Necrosis - Abdomen * 1  1/169 (0.59%)  0/215 (0.00%) 
Muscle Weakness - Whole Body/Generalized * 1  1/169 (0.59%)  0/215 (0.00%) 
Muscle Weakness - Extremity-Lower * 1  1/169 (0.59%)  0/215 (0.00%) 
Nervous system disorders     
Mental Status * 1  0/169 (0.00%)  1/215 (0.47%) 
Mood Alteration - Depression * 1  1/169 (0.59%)  0/215 (0.00%) 
Mood Alteration - Anxiety * 1  3/169 (1.78%)  2/215 (0.93%) 
Dizziness * 1  2/169 (1.18%)  0/215 (0.00%) 
Neuropathy-Sensory * 1  2/169 (1.18%)  3/215 (1.40%) 
Neuropathy-Motor * 1  0/169 (0.00%)  1/215 (0.47%) 
Renal and urinary disorders     
Renal/Genitourinary - Other * 1  2/169 (1.18%)  2/215 (0.93%) 
Leak, Gu - Ureter * 1  0/169 (0.00%)  1/215 (0.47%) 
Cystitis * 1  1/169 (0.59%)  0/215 (0.00%) 
Urinary Retention * 1  3/169 (1.78%)  2/215 (0.93%) 
Obstruction, Gu - Ureter * 1  2/169 (1.18%)  0/215 (0.00%) 
Incontinence, Urinary * 1  0/169 (0.00%)  1/215 (0.47%) 
Bladder Spasm * 1  0/169 (0.00%)  2/215 (0.93%) 
Renal Failure * 1  0/169 (0.00%)  1/215 (0.47%) 
Urinary Frequency * 1  3/169 (1.78%)  2/215 (0.93%) 
Reproductive system and breast disorders     
Vaginal Discharge * 1  2/169 (1.18%)  1/215 (0.47%) 
Respiratory, thoracic and mediastinal disorders     
Edema, Larynx * 1  1/169 (0.59%)  0/215 (0.00%) 
Atelectasis * 1  0/169 (0.00%)  1/215 (0.47%) 
Pneumothorax * 1  1/169 (0.59%)  0/215 (0.00%) 
Hypoxia * 1  3/169 (1.78%)  0/215 (0.00%) 
Cough * 1  1/169 (0.59%)  2/215 (0.93%) 
Pleural Effusion * 1  0/169 (0.00%)  1/215 (0.47%) 
Dyspnea * 1  3/169 (1.78%)  1/215 (0.47%) 
Skin and subcutaneous tissue disorders     
Hair Loss/Alopecia (Scalp Or Body) * 1  0/169 (0.00%)  1/215 (0.47%) 
Wound Complication, Non-Infectious * 1  1/169 (0.59%)  7/215 (3.26%) 
Bruising * 1  0/169 (0.00%)  2/215 (0.93%) 
Rash * 1  3/169 (1.78%)  0/215 (0.00%) 
Pruritus * 1  2/169 (1.18%)  0/215 (0.00%) 
Dermatology/Skin - Other * 1  2/169 (1.18%)  0/215 (0.00%) 
Surgical and medical procedures     
Intra-Op Injury: Vein-Inferior Vena Cava * 1  0/169 (0.00%)  1/215 (0.47%) 
Intra-Op Injury: Bladder * 1  0/169 (0.00%)  1/215 (0.47%) 
Vascular disorders     
Inr * 1  0/169 (0.00%)  2/215 (0.93%) 
Coagulopathy - Other * 1  1/169 (0.59%)  0/215 (0.00%) 
Hemorrhage, Gu - Vagina * 1  6/169 (3.55%)  2/215 (0.93%) 
Hemorrhage, Gi - Upper Gi Nos * 1  1/169 (0.59%)  0/215 (0.00%) 
Hematoma * 1  0/169 (0.00%)  2/215 (0.93%) 
Hemorrhage, Gi - Abdomen Nos * 1  0/169 (0.00%)  1/215 (0.47%) 
Petechiae * 1  1/169 (0.59%)  0/215 (0.00%) 
Hemorrhage/Bleeding - Other * 1  0/169 (0.00%)  1/215 (0.47%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  1/169 (0.59%)  2/215 (0.93%) 
Thrombosis/Thrombus/Embolism * 1  4/169 (2.37%)  1/215 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Relatively small number of patients with abdominal metastasis in both cervical and endometrial cancer cohorts
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center
Phone: 716-845-7733
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416455     History of Changes
Other Study ID Numbers: NCI-2009-00600
NCI-2009-00600 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000521453
ACRIN 6671
GOG-0233/ACRIN 6671
GOG-0233-ACRIN 6671 ( Other Identifier: NRG Oncology )
GOG-0233 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2006
First Posted: December 28, 2006
Results First Submitted: November 9, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 7, 2018