Trial Outcomes & Findings for Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma (NCT NCT00782756)
NCT ID: NCT00782756
Last Updated: 2018-02-06
Results Overview
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2018-02-06
Participant Flow
Participant milestones
| Measure |
RT, With Temozolomide and Bevacizumab
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Baseline characteristics by cohort
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 Participants
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearSafety assessments and toxicity grading will follow CTCAE Version 4 Grade
Outcome measures
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 Participants
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
|
|---|---|
|
Number of Participants With Adverse Events
|
40 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearOutcome measures
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 Participants
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
|
|---|---|
|
Progression Free Survival
|
10 months
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearPopulation: 37 participants agreed to undergo neuropsychological evaluations.
Outcome measures
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 Participants
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
|
|---|---|
|
Neurocognitive Outcome
Neuropsychological evaluations
|
37 Participants
|
|
Neurocognitive Outcome
Did not agree to neuropsychological evaluations
|
3 Participants
|
Adverse Events
RT, With Temozolomide and Bevacizumab
Serious events: 19 serious events
Other events: 40 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 participants at risk
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • 1 year
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • 1 year
|
|
Investigations
Creatinine
|
5.0%
2/40 • 1 year
|
|
Renal and urinary disorders
Glomerular filtration rate
|
2.5%
1/40 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Hemorrhage, CNS
|
2.5%
1/40 • 1 year
|
|
Infections and infestations
Infection, other
|
5.0%
2/40 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
2.5%
1/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Left-sided
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • 1 year
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
5.0%
2/40 • 1 year
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
2.5%
1/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Pain - Head/headache
|
5.0%
2/40 • 1 year
|
|
Psychiatric disorders
Personality/behavioral
|
2.5%
1/40 • 1 year
|
|
Investigations
Platelets
|
15.0%
6/40 • 1 year
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
5.0%
2/40 • 1 year
|
|
Nervous system disorders
Seizure
|
32.5%
13/40 • 1 year
|
|
Nervous system disorders
Speech impairment
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.5%
3/40 • 1 year
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
7.5%
3/40 • 1 year
|
|
Nervous system disorders
Vasovagal episode
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • 1 year
|
Other adverse events
| Measure |
RT, With Temozolomide and Bevacizumab
n=40 participants at risk
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
|
|---|---|
|
General disorders
Fatigue
|
72.5%
29/40 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
45.0%
18/40 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
37.5%
15/40 • 1 year
|
|
Nervous system disorders
Headache
|
25.0%
10/40 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
17.5%
7/40 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
6/40 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
30.0%
12/40 • 1 year
|
|
Injury, poisoning and procedural complications
Hemorrhage/Bleeding - other
|
10.0%
4/40 • 1 year
|
|
Vascular disorders
Hypertension
|
10.0%
4/40 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
7.5%
3/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • 1 year
|
|
Investigations
Leukocytes (total WBC)
|
7.5%
3/40 • 1 year
|
|
Nervous system disorders
Neuropathy - sensory
|
7.5%
3/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
7.5%
3/40 • 1 year
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.0%
2/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Nose
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Oral cavity
|
5.0%
2/40 • 1 year
|
|
Nervous system disorders
Memory Impairment
|
5.0%
2/40 • 1 year
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
5.0%
2/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain - neck
|
5.0%
2/40 • 1 year
|
|
Investigations
Platelets
|
5.0%
2/40 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
2/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.0%
2/40 • 1 year
|
|
Nervous system disorders
Seizure
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
2/40 • 1 year
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.0%
2/40 • 1 year
|
|
Eye disorders
Vision-blurred vision
|
5.0%
2/40 • 1 year
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
5.0%
2/40 • 1 year
|
Additional Information
Dr. Philip Gutin
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8556
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place