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Fludeoxyglucose 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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2014 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416455
First received: December 27, 2006
Last updated: November 9, 2015
Last verified: July 2014
Results First Received: November 9, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 closed to accrual on 6/21/2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cervical Cancer Patients 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
Endometrial Cancer 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

Participant Flow:   Overall Study
    Cervical Cancer Patients     Endometrial Cancer Patients  
STARTED     169 [1]   215 [1]
COMPLETED     153 [2]   207 [2]
NOT COMPLETED     16     8  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adequate imaging and pathologically eligible patients (N =360)

Reporting Groups
  Description
Cervical Cancer Patients 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
Endometrial Cancer 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
Total Total of all reporting groups

Baseline Measures
    Cervical Cancer Patients     Endometrial Cancer Patients     Total  
Number of Participants  
[units: participants]
  153     207     360  
Age  
[units: years]
Mean (Standard Deviation)
  49  (11.6)     64.8  (9.9)     58  (13.2)  
Gender  
[units: participants]
     
Female     153     207     360  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen   [ Time Frame: Before surgery (FDG-PET-CT) and after surgery (pathology) ]

2.  Primary:   Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen   [ Time Frame: Before surgery (DCT) and after surgery (pathology) ]

3.  Primary:   Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis   [ Time Frame: Before surgery (FDG-PET-CT) and after surgery (pathology) ]

4.  Primary:   Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis   [ Time Frame: Before surgery (DCT) and after surgery (pathology) ]

5.  Secondary:   Comparison of the Diagnostic Sensitivity and Specificity of PET/CT Scan vs PET Scanning Alone in Identifying Metastases to Pelvic, Abdominal, and Combined (All Regions) Lymph Nodes   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Comparison of the Diagnostic Sensitivity and Specificity of Ferumoxtran-10 MRI vs MRI Alone, in Terms of Size Criteria in the Abdomen and Pelvis   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Percentage of Patients With Locoregionally Advanced Cervical Cancer or High-risk Endometrial Cancer Who Have Biopsy-proven Disease Outside the Abdominal or Pelvic Lymph Nodes Detected by PET/CT Scanning   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Accuracy of MRI in Determining the Depth of Myometrial Invasion and Involvement of Cervix in Patients With High-risk Endometrial Cancer   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Complications Associated With Extraperitoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy in Patients With Locoregionally Advanced Cervical Cancer   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Cause(s) of Delay in the Initiation of Radiotherapy or Interruption in Radiotherapy in Patients With Locoregionally Advanced Cervical Cancer   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Relatively small number of patients with abdominal metastasis in both cervical and endometrial cancer cohorts


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: kurasa@nrgoncology.org



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 ( US NIH Grant/Contract Award Number )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: December 27, 2006
Results First Received: November 9, 2015
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration