Trial Outcomes & Findings for Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment (NCT NCT01015534)
NCT ID: NCT01015534
Last Updated: 2013-05-08
Results Overview
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
90 days
Results posted on
2013-05-08
Participant Flow
Participants were recruited from patients from Instituto Nacional de Cancerología de México, from January 2006 to September 2008.
Seventy-two patients were assessed for eligibility. Twelve patients did not meet inclusion criteria. Five patients declined to participate. Fifty-five patients were enrolled.
Participant milestones
| Measure |
Whole Brain Irradiation and Temozolomide
Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
|
Whole Brain Irradiation
Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Baseline characteristics by cohort
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 Participants
Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 Participants
Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age Continuous
|
49.5 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
53.8 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
51.7 years
STANDARD_DEVIATION 13.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
55 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Data on all enrolled participants were included in an intention-to-treat analysis.
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
Outcome measures
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 Participants
Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 Participants
Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
|
|---|---|---|
|
Objective Response Rates. Assessed With Cranial MRI
|
78.6 Percentage of participants with OR
Interval 63.4 to 93.8
|
48.1 Percentage of participants with OR
Interval 29.2 to 66.9
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Data on all enrolled participants were included in an intention-to-treat analysis.
Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.
Outcome measures
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 Participants
Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 Participants
Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
|
|---|---|---|
|
Survival Free of Brain Metastases Progression (PFS of BM)
|
88.7 Percentage of Participants
Interval 76.7 to 100.0
|
83.7 Percentage of Participants
Interval 69.0 to 98.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data on all enrolled participants were included in an intention-to-treat analysis.
Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Outcome measures
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 Participants
Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 Participants
Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
|
|---|---|---|
|
Overall Survival
|
8 Months of Overall Survival
Interval 4.9 to 11.1
|
8.1 Months of Overall Survival
Interval 5.9 to 10.1
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .
AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0 Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE.
Outcome measures
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 Participants
Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 Participants
Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
|
|---|---|---|
|
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Leukopenia
|
1 Events
|
0 Events
|
|
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Lymphopenia
|
11 Events
|
6 Events
|
|
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Nausea-Vomiting
|
1 Events
|
0 Events
|
|
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Neutropenia
|
1 Events
|
1 Events
|
|
Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Platelets
|
3 Events
|
0 Events
|
Adverse Events
Whole Brain Irradiation and Temozolomide
Serious events: 17 serious events
Other events: 11 other events
Deaths: 0 deaths
Whole Brain Irradiation
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 participants at risk
Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 participants at risk
Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
39.3%
11/28 • Number of events 11 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
22.2%
6/27 • Number of events 6 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.6%
1/28 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
0.00%
0/27 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Blood and lymphatic system disorders
Platelets
|
10.7%
3/28 • Number of events 3 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
0.00%
0/27 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.6%
1/28 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
3.7%
1/27 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Hepatobiliary disorders
Nausea-Vomiting
|
3.6%
1/28 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
0.00%
0/27 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
Other adverse events
| Measure |
Whole Brain Irradiation and Temozolomide
n=28 participants at risk
Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
|
Whole Brain Irradiation
n=27 participants at risk
Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.9%
5/28 • Number of events 5 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
40.7%
11/27 • Number of events 11 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Blood and lymphatic system disorders
platelets
|
10.7%
3/28 • Number of events 3 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
3.7%
1/27 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase - Aspartate aminotransferase
|
10.7%
3/28 • Number of events 3 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
3.7%
1/27 • Number of events 1 • 3 months
Patients were assessed as follows: with a Complete blood count at the end of the first and second week of treatment. A standard biochemical profile at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Also were evaluated clinically with the same periodicity.
|
Additional Information
Carlos Gamboa Vignolle/ Radiation Oncologist
Instituto Nacional de Cancerologia de Mexico
Phone: 0155556280400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place