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Trial record 3 of 3 for:    "Cervical Adenocarcinoma" | "Mitogens"

Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical 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: NCT00369122
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : May 17, 2013
Last Update Posted : March 20, 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 Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Stage IB Cervical Cancer AJCC v6 and v7
Stage IIA Cervical Cancer AJCC v7
Stage IIB Cervical Cancer AJCC v6 and v7
Stage III Cervical Cancer AJCC v6 and v7
Interventions Biological: Bevacizumab
Drug: Cisplatin
Radiation: External Beam Radiation Therapy
Radiation: Internal Radiation Therapy
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Period Title: Overall Study
Started 60
Completed 49 [1]
Not Completed 11
Reason Not Completed
Ineligible             10
No protocol treatment             1
[1]
Subjects contributing data to the primary analysis are considered to have completed the study.
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
45.5
(20 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
60
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.
Hide Description Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.
Time Frame From start of treatment to 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began study treatment.
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description:

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 0
Adverse Events 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate >=20% and AE rate >=55% excessive. If there were >=6 pts with SAES or >=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.
2.Secondary Outcome
Title Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.
Hide Description Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.
Time Frame From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description:

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 0
Adverse Events 18
3.Secondary Outcome
Title Disease-free Survival (Three-year Rate Reported)
Hide Description Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description:

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.7
(53.5 to 79.8)
4.Secondary Outcome
Title Overall Survival (Three-year Rate Reported)
Hide Description Overall survival time is defined as time from registration 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 registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description:

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.3
(67.2 to 89.8)
Time Frame [Not Specified]
Adverse Event Reporting Description Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
 
Arm/Group Title Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Hide Arm/Group Description

Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.

Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.

Data is reported for all patients who received study treatment, which is 59 patients.

All-Cause Mortality
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Affected / at Risk (%)
Total   13/59 (22.03%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  1/59 (1.69%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/59 (1.69%) 
Diarrhea * 1  2/59 (3.39%) 
Nausea * 1  1/59 (1.69%) 
Proctitis * 1  1/59 (1.69%) 
Rectal pain * 1  1/59 (1.69%) 
Vomiting * 1  1/59 (1.69%) 
General disorders   
Fever * 1  1/59 (1.69%) 
Immune system disorders   
Allergic reaction * 1  1/59 (1.69%) 
Infections and infestations   
Bladder infection * 1  1/59 (1.69%) 
Catheter related infection * 1  1/59 (1.69%) 
Lung infection * 1  1/59 (1.69%) 
Injury, poisoning and procedural complications   
Vascular access complication * 1  1/59 (1.69%) 
Investigations   
GGT increased * 1  1/59 (1.69%) 
Lymphocyte count decreased * 1  2/59 (3.39%) 
Neutrophil count decreased * 1  1/59 (1.69%) 
Platelet count decreased * 1  2/59 (3.39%) 
White blood cell decreased * 1  1/59 (1.69%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/59 (1.69%) 
Dehydration * 1  3/59 (5.08%) 
Hyperglycemia * 1  1/59 (1.69%) 
Hypokalemia * 1  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/59 (1.69%) 
Nervous system disorders   
Syncope * 1  1/59 (1.69%) 
Psychiatric disorders   
Depression * 1  1/59 (1.69%) 
Renal and urinary disorders   
Urinary tract obstruction * 1  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage * 1  1/59 (1.69%) 
Vascular disorders   
Thromboembolic event * 1  1/59 (1.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
Affected / at Risk (%)
Total   59/59 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  32/59 (54.24%) 
Ear and labyrinth disorders   
Hearing impaired * 1  1/59 (1.69%) 
Tinnitus * 1  4/59 (6.78%) 
Eye disorders   
Blurred vision * 1  1/59 (1.69%) 
Extraocular muscle paresis * 1  1/59 (1.69%) 
Flashing lights * 1  1/59 (1.69%) 
Gastrointestinal disorders   
Abdominal distension * 1  1/59 (1.69%) 
Abdominal pain * 1  11/59 (18.64%) 
Anal fistula * 1  1/59 (1.69%) 
Anal pain * 1  1/59 (1.69%) 
Colitis * 1  1/59 (1.69%) 
Constipation * 1  17/59 (28.81%) 
Diarrhea * 1  30/59 (50.85%) 
Dry mouth * 1  1/59 (1.69%) 
Dyspepsia * 1  4/59 (6.78%) 
Dysphagia * 1  2/59 (3.39%) 
Esophagitis * 1  1/59 (1.69%) 
Gastritis * 1  1/59 (1.69%) 
Gastrointestinal disorders - Other * 1  2/59 (3.39%) 
Hemorrhoids * 1  3/59 (5.08%) 
Mucositis oral * 1  2/59 (3.39%) 
Nausea * 1  32/59 (54.24%) 
Proctitis * 1  4/59 (6.78%) 
Rectal hemorrhage * 1  5/59 (8.47%) 
Rectal pain * 1  5/59 (8.47%) 
Vomiting * 1  15/59 (25.42%) 
General disorders   
Chills * 1  4/59 (6.78%) 
Edema limbs * 1  4/59 (6.78%) 
Fatigue * 1  34/59 (57.63%) 
Fever * 1  4/59 (6.78%) 
General disorders and administration site conditions - Other * 1  1/59 (1.69%) 
Non-cardiac chest pain * 1  1/59 (1.69%) 
Pain * 1  4/59 (6.78%) 
Infections and infestations   
Infections and infestations - Other * 1  4/59 (6.78%) 
Sinusitis * 1  1/59 (1.69%) 
Soft tissue infection * 1  1/59 (1.69%) 
Urinary tract infection * 1  3/59 (5.08%) 
Vaginal infection * 1  3/59 (5.08%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  6/59 (10.17%) 
Ureteric anastomotic leak * 1  1/59 (1.69%) 
Investigations   
Activated partial thromboplastin time prolonged * 1  2/59 (3.39%) 
Alanine aminotransferase increased * 1  8/59 (13.56%) 
Alkaline phosphatase increased * 1  5/59 (8.47%) 
Aspartate aminotransferase increased * 1  5/59 (8.47%) 
Blood bilirubin increased * 1  1/59 (1.69%) 
Cholesterol high * 1  1/59 (1.69%) 
Creatinine increased * 1  5/59 (8.47%) 
Investigations - Other * 1  3/59 (5.08%) 
Lymphocyte count decreased * 1  17/59 (28.81%) 
Neutrophil count decreased * 1  17/59 (28.81%) 
Platelet count decreased * 1  26/59 (44.07%) 
Weight gain * 1  3/59 (5.08%) 
Weight loss * 1  8/59 (13.56%) 
White blood cell decreased * 1  41/59 (69.49%) 
Metabolism and nutrition disorders   
Acidosis * 1  2/59 (3.39%) 
Anorexia * 1  11/59 (18.64%) 
Dehydration * 1  2/59 (3.39%) 
Hypercalcemia * 1  7/59 (11.86%) 
Hyperglycemia * 1  17/59 (28.81%) 
Hyperkalemia * 1  2/59 (3.39%) 
Hypernatremia * 1  1/59 (1.69%) 
Hyperuricemia * 1  2/59 (3.39%) 
Hypoalbuminemia * 1  13/59 (22.03%) 
Hypocalcemia * 1  11/59 (18.64%) 
Hypoglycemia * 1  2/59 (3.39%) 
Hypokalemia * 1  17/59 (28.81%) 
Hypomagnesemia * 1  23/59 (38.98%) 
Hyponatremia * 1  16/59 (27.12%) 
Hypophosphatemia * 1  2/59 (3.39%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  5/59 (8.47%) 
Back pain * 1  6/59 (10.17%) 
Bone pain * 1  1/59 (1.69%) 
Joint range of motion decreased * 1  1/59 (1.69%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/59 (1.69%) 
Myalgia * 1  2/59 (3.39%) 
Neck pain * 1  1/59 (1.69%) 
Pain in extremity * 1  1/59 (1.69%) 
Nervous system disorders   
Dizziness * 1  5/59 (8.47%) 
Dysgeusia * 1  5/59 (8.47%) 
Facial nerve disorder * 1  1/59 (1.69%) 
Headache * 1  12/59 (20.34%) 
Nervous system disorders - Other * 1  3/59 (5.08%) 
Peripheral motor neuropathy * 1  1/59 (1.69%) 
Peripheral sensory neuropathy * 1  5/59 (8.47%) 
Psychiatric disorders   
Agitation * 1  1/59 (1.69%) 
Anxiety * 1  8/59 (13.56%) 
Depression * 1  8/59 (13.56%) 
Insomnia * 1  8/59 (13.56%) 
Renal and urinary disorders   
Bladder spasm * 1  1/59 (1.69%) 
Chronic kidney disease * 1  1/59 (1.69%) 
Cystitis noninfective * 1  5/59 (8.47%) 
Hemoglobinuria * 1  2/59 (3.39%) 
Proteinuria * 1  1/59 (1.69%) 
Renal and urinary disorders - Other * 1  3/59 (5.08%) 
Urinary frequency * 1  8/59 (13.56%) 
Urinary incontinence * 1  3/59 (5.08%) 
Urinary retention * 1  1/59 (1.69%) 
Urinary tract obstruction * 1  1/59 (1.69%) 
Urinary tract pain * 1  4/59 (6.78%) 
Reproductive system and breast disorders   
Irregular menstruation * 1  4/59 (6.78%) 
Lactation disorder * 1  1/59 (1.69%) 
Pelvic pain * 1  11/59 (18.64%) 
Perineal pain * 1  3/59 (5.08%) 
Reproductive system and breast disorders - Other * 1  1/59 (1.69%) 
Uterine hemorrhage * 1  1/59 (1.69%) 
Uterine obstruction * 1  1/59 (1.69%) 
Uterine pain * 1  2/59 (3.39%) 
Vaginal discharge * 1  11/59 (18.64%) 
Vaginal dryness * 1  1/59 (1.69%) 
Vaginal fistula * 1  1/59 (1.69%) 
Vaginal hemorrhage * 1  25/59 (42.37%) 
Vaginal inflammation * 1  5/59 (8.47%) 
Vaginal obstruction * 1  6/59 (10.17%) 
Vaginal pain * 1  4/59 (6.78%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage * 1  1/59 (1.69%) 
Cough * 1  3/59 (5.08%) 
Dyspnea * 1  5/59 (8.47%) 
Epistaxis * 1  3/59 (5.08%) 
Voice alteration * 1  5/59 (8.47%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  2/59 (3.39%) 
Dry skin * 1  2/59 (3.39%) 
Hyperhidrosis * 1  2/59 (3.39%) 
Pruritus * 1  2/59 (3.39%) 
Rash acneiform * 1  1/59 (1.69%) 
Rash maculo-papular * 1  5/59 (8.47%) 
Skin and subcutaneous tissue disorders - Other * 1  2/59 (3.39%) 
Skin hypopigmentation * 1  1/59 (1.69%) 
Skin induration * 1  2/59 (3.39%) 
Skin ulceration * 1  1/59 (1.69%) 
Telangiectasia * 1  2/59 (3.39%) 
Vascular disorders   
Flushing * 1  1/59 (1.69%) 
Hot flashes * 1  14/59 (23.73%) 
Hypertension * 1  6/59 (10.17%) 
Hypotension * 1  5/59 (8.47%) 
Vascular disorders - Other * 1  2/59 (3.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Ineligible patients are included in the adverse event reporting on ClinicalTrials.gov, but not in endpoint results, nor in any publications, per the protocol.
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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00369122     History of Changes
Obsolete Identifiers: NCT01530633
Other Study ID Numbers: NCI-2009-00722
NCI-2009-00722 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000493005
RTOG 0417 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0417 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: March 5, 2013
Results First Posted: May 17, 2013
Last Update Posted: March 20, 2018