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Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01005329
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : February 24, 2014
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
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: Treatment
Conditions Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage IA Uterine Corpus Cancer AJCC v7
Stage IB Uterine Corpus Cancer AJCC v7
Stage II Uterine Corpus Cancer AJCC v7
Stage IIIA Uterine Corpus Cancer AJCC v7
Stage IIIB Uterine Corpus Cancer AJCC v7
Stage IIIC Uterine Corpus Cancer AJCC v7
Stage IVA Uterine Corpus Cancer AJCC v7
Stage IVB Uterine Corpus Cancer AJCC v7
Interventions Biological: Bevacizumab
Drug: Carboplatin
Drug: Cisplatin
Radiation: Intensity-Modulated Radiation Therapy
Drug: Paclitaxel
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 34
Completed 30 [1]
Not Completed 4
Reason Not Completed
Ineligible or received no protocol trt.             4
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
All eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
59
(34 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
Hide Description Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of treatment to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
23.3
(10.63 to 36.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemoradiation (IMRT), Chemotherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.
2.Secondary Outcome
Title Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start
Hide Description Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment.
Time Frame From start of treatment to one year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.3
(28.5 to 58.2)
3.Secondary Outcome
Title Treatment-related Grade 3+ Adverse Events
Hide Description The highest grade adverse event per patient reported as definitely, probably, or possibly related to study treatment is counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0
1
   3.3%
Grade 1
0
   0.0%
Grade 2
8
  26.7%
Grade 3
12
  40.0%
Grade 4
9
  30.0%
Grade 5
0
   0.0%
4.Secondary Outcome
Title Overall Survival (Two-year Rate Reported)
Hide Description Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.7
(78.6 to 99.5)
5.Secondary Outcome
Title Disease-free Survival (Two-year Rate Reported)
Hide Description Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.1
(59.2 to 90.1)
6.Secondary Outcome
Title Pelvic Failure Rate (Two-year Rate Reported)
Hide Description Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
7.Secondary Outcome
Title Distant Failure (Two-year Rate Reported)
Hide Description Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method.
Time Frame From registration to two years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description:
Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
17.0
(3.2 to 30.9)
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
 
Arm/Group Title Chemoradiation (IMRT), Chemotherapy
Hide Arm/Group Description Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Chemoradiation (IMRT), Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Chemoradiation (IMRT), Chemotherapy
Affected / at Risk (%)
Total   8/30 (26.67%) 
Blood and lymphatic system disorders   
Anemia * 1  2/30 (6.67%) 
Febrile neutropenia * 1  1/30 (3.33%) 
Gastrointestinal disorders   
Diarrhea * 1  1/30 (3.33%) 
Esophageal pain * 1  1/30 (3.33%) 
Infections and infestations   
Skin infection * 1  1/30 (3.33%) 
Urinary tract infection * 1  1/30 (3.33%) 
Investigations   
Lymphocyte count decreased * 1  2/30 (6.67%) 
Neutrophil count decreased * 1  2/30 (6.67%) 
Platelet count decreased * 1  1/30 (3.33%) 
White blood cell decreased * 1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Hypoalbuminemia * 1  1/30 (3.33%) 
Hypokalemia * 1  1/30 (3.33%) 
Hyponatremia * 1  1/30 (3.33%) 
Nervous system disorders   
Neuralgia * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/30 (3.33%) 
Vascular disorders   
Thromboembolic event * 1  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemoradiation (IMRT), Chemotherapy
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  22/30 (73.33%) 
Blood and lymphatic system disorders - Other, specify * 1  2/30 (6.67%) 
Cardiac disorders   
Chest pain - cardiac * 1  1/30 (3.33%) 
Palpitations * 1  2/30 (6.67%) 
Sinus tachycardia * 1  2/30 (6.67%) 
Ear and labyrinth disorders   
Ear pain * 1  3/30 (10.00%) 
Hearing impaired * 1  4/30 (13.33%) 
Tinnitus * 1  5/30 (16.67%) 
Eye disorders   
Blurred vision * 1  8/30 (26.67%) 
Eye disorders - Other, specify * 1  1/30 (3.33%) 
Eye pain * 1  1/30 (3.33%) 
Floaters * 1  2/30 (6.67%) 
Photophobia * 1  1/30 (3.33%) 
Gastrointestinal disorders   
Abdominal pain * 1  9/30 (30.00%) 
Anal mucositis * 1  1/30 (3.33%) 
Anal pain * 1  3/30 (10.00%) 
Bloating * 1  7/30 (23.33%) 
Constipation * 1  18/30 (60.00%) 
Dental caries * 1  1/30 (3.33%) 
Diarrhea * 1  22/30 (73.33%) 
Dry mouth * 1  1/30 (3.33%) 
Dyspepsia * 1  7/30 (23.33%) 
Dysphagia * 1  2/30 (6.67%) 
Esophageal pain * 1  1/30 (3.33%) 
Fecal incontinence * 1  2/30 (6.67%) 
Flatulence * 1  2/30 (6.67%) 
Gastroesophageal reflux disease * 1  2/30 (6.67%) 
Gastrointestinal disorders - Other, specify * 1  2/30 (6.67%) 
Gastrointestinal pain * 1  1/30 (3.33%) 
Hemorrhoids * 1  3/30 (10.00%) 
Mucositis oral * 1  5/30 (16.67%) 
Nausea * 1  19/30 (63.33%) 
Proctitis * 1  3/30 (10.00%) 
Rectal hemorrhage * 1  4/30 (13.33%) 
Rectal pain * 1  3/30 (10.00%) 
Salivary duct inflammation * 1  1/30 (3.33%) 
Vomiting * 1  11/30 (36.67%) 
General disorders   
Chills * 1  3/30 (10.00%) 
Edema face * 1  2/30 (6.67%) 
Edema limbs * 1  8/30 (26.67%) 
Fatigue * 1  26/30 (86.67%) 
Fever * 1  1/30 (3.33%) 
Flu like symptoms * 1  1/30 (3.33%) 
Gait disturbance * 1  1/30 (3.33%) 
General disorders and administration site conditions - Other, specify * 1  3/30 (10.00%) 
Localized edema * 1  1/30 (3.33%) 
Pain * 1  5/30 (16.67%) 
Infections and infestations   
Bladder infection * 1  2/30 (6.67%) 
Infections and infestations - Other, specify * 1  2/30 (6.67%) 
Lung infection * 1  1/30 (3.33%) 
Skin infection * 1  1/30 (3.33%) 
Tooth infection * 1  1/30 (3.33%) 
Upper respiratory infection * 1  1/30 (3.33%) 
Urethral infection * 1  1/30 (3.33%) 
Urinary tract infection * 1  4/30 (13.33%) 
Vaginal infection * 1  1/30 (3.33%) 
Wound infection * 1  1/30 (3.33%) 
Injury, poisoning and procedural complications   
Ankle fracture * 1  1/30 (3.33%) 
Dermatitis radiation * 1  5/30 (16.67%) 
Radiation recall reaction (dermatologic) * 1  1/30 (3.33%) 
Investigations   
Alanine aminotransferase increased * 1  6/30 (20.00%) 
Alkaline phosphatase increased * 1  3/30 (10.00%) 
Aspartate aminotransferase increased * 1  6/30 (20.00%) 
Blood bilirubin increased * 1  1/30 (3.33%) 
Cholesterol high * 1  1/30 (3.33%) 
Creatinine increased * 1  5/30 (16.67%) 
GGT increased * 1  2/30 (6.67%) 
Hemoglobin increased * 1  1/30 (3.33%) 
Investigations - Other, specify * 1  6/30 (20.00%) 
Lymphocyte count decreased * 1  19/30 (63.33%) 
Lymphocyte count increased * 1  2/30 (6.67%) 
Neutrophil count decreased * 1  17/30 (56.67%) 
Platelet count decreased * 1  16/30 (53.33%) 
Weight gain * 1  2/30 (6.67%) 
Weight loss * 1  6/30 (20.00%) 
White blood cell decreased * 1  23/30 (76.67%) 
Metabolism and nutrition disorders   
Anorexia * 1  11/30 (36.67%) 
Dehydration * 1  4/30 (13.33%) 
Hypercalcemia * 1  3/30 (10.00%) 
Hyperglycemia * 1  19/30 (63.33%) 
Hypertriglyceridemia * 1  1/30 (3.33%) 
Hyperuricemia * 1  3/30 (10.00%) 
Hypoalbuminemia * 1  7/30 (23.33%) 
Hypocalcemia * 1  5/30 (16.67%) 
Hypoglycemia * 1  1/30 (3.33%) 
Hypokalemia * 1  6/30 (20.00%) 
Hypomagnesemia * 1  15/30 (50.00%) 
Hyponatremia * 1  6/30 (20.00%) 
Hypophosphatemia * 1  2/30 (6.67%) 
Metabolism and nutrition disorders - Other, specify * 1  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  3/30 (10.00%) 
Arthritis * 1  1/30 (3.33%) 
Back pain * 1  7/30 (23.33%) 
Bone pain * 1  2/30 (6.67%) 
Buttock pain * 1  1/30 (3.33%) 
Flank pain * 1  1/30 (3.33%) 
Generalized muscle weakness * 1  3/30 (10.00%) 
Muscle weakness lower limb * 1  1/30 (3.33%) 
Musculoskeletal and connective tissue disorder - Other, specify * 1  4/30 (13.33%) 
Myalgia * 1  6/30 (20.00%) 
Neck pain * 1  1/30 (3.33%) 
Pain in extremity * 1  7/30 (23.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify * 1  1/30 (3.33%) 
Tumor pain * 1  1/30 (3.33%) 
Nervous system disorders   
Cognitive disturbance * 1  1/30 (3.33%) 
Concentration impairment * 1  1/30 (3.33%) 
Dizziness * 1  6/30 (20.00%) 
Dysgeusia * 1  3/30 (10.00%) 
Extrapyramidal disorder * 1  1/30 (3.33%) 
Headache * 1  12/30 (40.00%) 
Neuralgia * 1  1/30 (3.33%) 
Paresthesia * 1  5/30 (16.67%) 
Peripheral motor neuropathy * 1  4/30 (13.33%) 
Peripheral sensory neuropathy * 1  14/30 (46.67%) 
Syncope * 1  2/30 (6.67%) 
Psychiatric disorders   
Agitation * 1  1/30 (3.33%) 
Anxiety * 1  7/30 (23.33%) 
Depression * 1  7/30 (23.33%) 
Insomnia * 1  5/30 (16.67%) 
Renal and urinary disorders   
Acute kidney injury * 1  1/30 (3.33%) 
Bladder spasm * 1  1/30 (3.33%) 
Cystitis noninfective * 1  3/30 (10.00%) 
Hematuria * 1  2/30 (6.67%) 
Renal and urinary disorders - Other, specify * 1  5/30 (16.67%) 
Urinary frequency * 1  8/30 (26.67%) 
Urinary incontinence * 1  5/30 (16.67%) 
Urinary retention * 1  1/30 (3.33%) 
Urinary tract pain * 1  8/30 (26.67%) 
Urinary urgency * 1  5/30 (16.67%) 
Reproductive system and breast disorders   
Breast pain * 1  2/30 (6.67%) 
Dyspareunia * 1  1/30 (3.33%) 
Pelvic pain * 1  1/30 (3.33%) 
Vaginal discharge * 1  6/30 (20.00%) 
Vaginal dryness * 1  7/30 (23.33%) 
Vaginal hemorrhage * 1  4/30 (13.33%) 
Vaginal inflammation * 1  3/30 (10.00%) 
Vaginal pain * 1  3/30 (10.00%) 
Vaginal stricture * 1  3/30 (10.00%) 
Vaginismus * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis * 1  1/30 (3.33%) 
Cough * 1  7/30 (23.33%) 
Dyspnea * 1  8/30 (26.67%) 
Epistaxis * 1  4/30 (13.33%) 
Hoarseness * 1  1/30 (3.33%) 
Nasal congestion * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders - Other, specify * 1  1/30 (3.33%) 
Sinus disorder * 1  1/30 (3.33%) 
Sore throat * 1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  17/30 (56.67%) 
Erythema multiforme * 1  3/30 (10.00%) 
Pain of skin * 1  1/30 (3.33%) 
Pruritus * 1  4/30 (13.33%) 
Rash acneiform * 1  3/30 (10.00%) 
Rash maculo-papular * 1  4/30 (13.33%) 
Scalp pain * 1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders - Other, specify * 1  3/30 (10.00%) 
Skin induration * 1  1/30 (3.33%) 
Telangiectasia * 1  3/30 (10.00%) 
Vascular disorders   
Hot flashes * 1  8/30 (26.67%) 
Hypertension * 1  9/30 (30.00%) 
Hypotension * 1  1/30 (3.33%) 
Lymphedema * 1  1/30 (3.33%) 
Lymphocele * 1  1/30 (3.33%) 
Thromboembolic event * 1  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
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Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
EMail: wseiferheld@gmail.com
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01005329    
Other Study ID Numbers: NCI-2011-01982
NCI-2011-01982 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000657979
RTOG-0921
RTOG 0921 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0921 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2009
First Posted: October 30, 2009
Results First Submitted: January 8, 2014
Results First Posted: February 24, 2014
Last Update Posted: March 15, 2018