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Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00331760
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : June 3, 2013
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Cancer
Endometrial Cancer
Interventions Drug: cisplatin
Radiation: intensity-modulated radiation therapy
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Period Title: Overall Study
Started 58 48
Completed 43 [1] 40
Not Completed 15 8
Reason Not Completed
Ineligible / no protocol treatment             15             8
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin) Total
Hide Arm/Group Description Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin) Total of all reporting groups
Overall Number of Baseline Participants 58 48 106
Hide Baseline Analysis Population Description
All registered patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants 48 participants 106 participants
58
(36 to 84)
43
(22 to 71)
53
(22 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 48 participants 106 participants
Female
58
 100.0%
48
 100.0%
106
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Hide Description

Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.

For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%.

Time Frame IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Unit of Measure: participants
1 0
2.Secondary Outcome
Title Percentage of Patients With Grade 2+ Bowel Adverse Events
Hide Description Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
Time Frame From the start of treatment to 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.9
(16.6 to 42.8)
22.5
(12.1 to 37.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endometrial Cancer: IMRT
Comments A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Comments A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
Hide Description Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Time Frame From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Non-hematologic
19
(9 to 33)
30
(18 to 46)
Overall
30
(19 to 45)
48
(33 to 63)
4.Secondary Outcome
Title Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
Hide Description Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
Time Frame From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Non-hematologic
12
(5 to 25)
10
(3 to 24)
Overall
12
(5 to 25)
10
(3 to 24)
5.Secondary Outcome
Title Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
Hide Description Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
Time Frame From start to end of chemotherapy, approximately five weeks from registration.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients in the chemotherapy group (cervical cancer patients) who started study treatment
Arm/Group Title Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80
(65 to 90)
6.Secondary Outcome
Title Rate of Local-regional Failure at Five Years
Hide Description Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.
Time Frame From registration to five years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5
(1 to 14)
8
(2 to 19)
7.Secondary Outcome
Title Rate of Distant Metastases at Five Years
Hide Description Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.
Time Frame From registration to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7
(2 to 17)
14
(5 to 27)
8.Secondary Outcome
Title Rate of Disease-free Survival at Five Years
Hide Description Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
Time Frame From registration five years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(74 to 95)
84
(68 to 92)
9.Secondary Outcome
Title Rate of Overall Survival at Five Years
Hide Description Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From randomization to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description:
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(74 to 95)
92
(77 to 97)
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible patients who started study treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Hide Arm/Group Description Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
All-Cause Mortality
Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/43 (4.65%)   3/40 (7.50%) 
Gastrointestinal disorders     
Diarrhoea NOS * 1  1/43 (2.33%)  1/40 (2.50%) 
Nausea * 1  1/43 (2.33%)  1/40 (2.50%) 
Rectal hemorrhage * 1  0/43 (0.00%)  1/40 (2.50%) 
Vomiting NOS * 1  0/43 (0.00%)  1/40 (2.50%) 
General disorders     
Fatigue * 1  0/43 (0.00%)  1/40 (2.50%) 
Infections and infestations     
Urinary tract infection NOS * 1  1/43 (2.33%)  0/40 (0.00%) 
Investigations     
Lymphopenia * 1  0/43 (0.00%)  1/40 (2.50%) 
Neutrophil count * 1  0/43 (0.00%)  1/40 (2.50%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/43 (0.00%)  1/40 (2.50%) 
Hypocalcemia * 1  0/43 (0.00%)  1/40 (2.50%) 
Hypokalemia * 1  0/43 (0.00%)  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/43 (2.33%)  0/40 (0.00%) 
Nervous system disorders     
Peripheral sensory neuropathy * 1  0/43 (0.00%)  1/40 (2.50%) 
Psychiatric disorders     
Depression * 1  1/43 (2.33%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Endometrial Cancer: IMRT Cervical Cancer: IMRT + Chemotherapy (Cisplatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   42/43 (97.67%)   39/40 (97.50%) 
Blood and lymphatic system disorders     
Hemoglobin * 1  11/43 (25.58%)  21/40 (52.50%) 
Ear and labyrinth disorders     
Hearing impaired * 1  0/43 (0.00%)  3/40 (7.50%) 
Tinnitus * 1  1/43 (2.33%)  5/40 (12.50%) 
Gastrointestinal disorders     
Abdominal distention * 1  1/43 (2.33%)  3/40 (7.50%) 
Abdominal pain NOS * 1  12/43 (27.91%)  10/40 (25.00%) 
Anal discomfort * 1  1/43 (2.33%)  2/40 (5.00%) 
Constipation * 1  5/43 (11.63%)  8/40 (20.00%) 
Diarrhoea NOS * 1  33/43 (76.74%)  33/40 (82.50%) 
Dyspepsia * 1  3/43 (6.98%)  2/40 (5.00%) 
Dysphagia * 1  0/43 (0.00%)  2/40 (5.00%) 
Enteritis * 1  6/43 (13.95%)  2/40 (5.00%) 
Flatulence * 1  1/43 (2.33%)  2/40 (5.00%) 
Gastritis NOS * 1  0/43 (0.00%)  2/40 (5.00%) 
Nausea * 1  14/43 (32.56%)  27/40 (67.50%) 
Proctitis NOS * 1  1/43 (2.33%)  5/40 (12.50%) 
Vomiting NOS * 1  1/43 (2.33%)  14/40 (35.00%) 
General disorders     
Fatigue * 1  20/43 (46.51%)  27/40 (67.50%) 
Pain NOS * 1  3/43 (6.98%)  1/40 (2.50%) 
Infections and infestations     
Gingival infection * 1  0/43 (0.00%)  2/40 (5.00%) 
Urinary tract infection NOS * 1  0/43 (0.00%)  3/40 (7.50%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  6/43 (13.95%)  6/40 (15.00%) 
Fracture NOS * 1  2/43 (4.65%)  2/40 (5.00%) 
Radiation recall syndrome * 1  1/43 (2.33%)  2/40 (5.00%) 
Investigations     
Alanine aminotransferase increased * 1  4/43 (9.30%)  5/40 (12.50%) 
Aspartate aminotransferase increased * 1  3/43 (6.98%)  1/40 (2.50%) 
Blood alkaline phosphatase increased * 1  3/43 (6.98%)  2/40 (5.00%) 
Blood bilirubin increased * 1  1/43 (2.33%)  2/40 (5.00%) 
Blood creatinine increased * 1  0/43 (0.00%)  3/40 (7.50%) 
Leukopenia NOS * 1  17/43 (39.53%)  26/40 (65.00%) 
Lymphopenia * 1  9/43 (20.93%)  18/40 (45.00%) 
Neutrophil count * 1  3/43 (6.98%)  5/40 (12.50%) 
Platelet count decreased * 1  7/43 (16.28%)  11/40 (27.50%) 
Weight decreased * 1  4/43 (9.30%)  5/40 (12.50%) 
Metabolism and nutrition disorders     
Anorexia * 1  4/43 (9.30%)  9/40 (22.50%) 
Dehydration * 1  1/43 (2.33%)  2/40 (5.00%) 
Hyperglycaemia NOS * 1  10/43 (23.26%)  7/40 (17.50%) 
Hypoalbuminemia * 1  3/43 (6.98%)  5/40 (12.50%) 
Hypokalemia * 1  5/43 (11.63%)  9/40 (22.50%) 
Hypomagnesemia * 1  5/43 (11.63%)  6/40 (15.00%) 
Hyponatremia * 1  2/43 (4.65%)  5/40 (12.50%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  5/43 (11.63%)  5/40 (12.50%) 
Buttock pain * 1  0/43 (0.00%)  2/40 (5.00%) 
Pain in extremity * 1  5/43 (11.63%)  3/40 (7.50%) 
Nervous system disorders     
Dizziness * 1  1/43 (2.33%)  2/40 (5.00%) 
Dysgeusia * 1  1/43 (2.33%)  6/40 (15.00%) 
Headache * 1  0/43 (0.00%)  4/40 (10.00%) 
Peripheral sensory neuropathy * 1  6/43 (13.95%)  5/40 (12.50%) 
Psychiatric disorders     
Agitation * 1  0/43 (0.00%)  2/40 (5.00%) 
Anxiety * 1  1/43 (2.33%)  6/40 (15.00%) 
Depression * 1  7/43 (16.28%)  3/40 (7.50%) 
Insomnia * 1  0/43 (0.00%)  6/40 (15.00%) 
Libido decreased * 1  3/43 (6.98%)  3/40 (7.50%) 
Renal and urinary disorders     
Bladder spasm * 1  0/43 (0.00%)  3/40 (7.50%) 
Cystitis NOS * 1  3/43 (6.98%)  7/40 (17.50%) 
Pollakiuria * 1  10/43 (23.26%)  10/40 (25.00%) 
Urethral pain * 1  1/43 (2.33%)  3/40 (7.50%) 
Urinary incontinence * 1  9/43 (20.93%)  7/40 (17.50%) 
Urinary retention * 1  1/43 (2.33%)  4/40 (10.00%) 
Reproductive system and breast disorders     
Pelvic pain NOS * 1  3/43 (6.98%)  5/40 (12.50%) 
Vaginal atresia * 1  6/43 (13.95%)  14/40 (35.00%) 
Vaginal discharge * 1  3/43 (6.98%)  8/40 (20.00%) 
Vaginal hemorrhage * 1  1/43 (2.33%)  4/40 (10.00%) 
Vaginal pain * 1  2/43 (4.65%)  4/40 (10.00%) 
Vaginal stricture * 1  3/43 (6.98%)  0/40 (0.00%) 
Vaginitis * 1  3/43 (6.98%)  2/40 (5.00%) 
Vulvovaginal dryness * 1  4/43 (9.30%)  6/40 (15.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/43 (2.33%)  3/40 (7.50%) 
Erythema multiforme * 1  0/43 (0.00%)  2/40 (5.00%) 
Telangiectasia * 1  3/43 (6.98%)  2/40 (5.00%) 
Vascular disorders     
Hot flushes NOS * 1  4/43 (9.30%)  19/40 (47.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
EMail: wseiferheld@acr.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00331760    
Other Study ID Numbers: RTOG-0418
CDR0000472905
First Submitted: May 30, 2006
First Posted: May 31, 2006
Results First Submitted: April 12, 2013
Results First Posted: June 3, 2013
Last Update Posted: February 26, 2019