Trial Outcomes & Findings for Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572) (NCT NCT00686725)
NCT ID: NCT00686725
Last Updated: 2017-06-14
Results Overview
OS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Temozolomide + Radiation
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
52
|
|
Overall Study
COMPLETED
|
1
|
10
|
|
Overall Study
NOT COMPLETED
|
46
|
42
|
Reasons for withdrawal
| Measure |
Temozolomide + Radiation
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Progressive Disease
|
17
|
23
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)
Baseline characteristics by cohort
| Measure |
Temozolomide + Radiation
n=47 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=52 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 10.12 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 13.04 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
47 participants
n=5 Participants
|
52 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsOS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=47 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=52 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
13.17 months
Interval 11.14 to 18.76
|
17.58 months
Interval 15.18 to 23.03
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death. PFS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=47 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=52 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
10.38 months
Interval 8.18 to 15.44
|
8.74 months
Interval 6.41 to 14.85
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall response was based on neuroimaging (magnetic resonance imaging \[MRI\]), clinical neurological examination, and steroid administration. It was assessed as follows: Complete Response (CR): Disappearance of all enhancing tumor (measurable or non-measurable), no corticosteroid use, and neurologically stable or improved. Partial Response (PR): ≥50% reduction in size of enhancing tumor (measurable or non-measurable) for any measurable lesions or definite improvement for any non-measurable lesions, corticosteroid dosage stable or reduced, and neurologically stable or improved. Progressive Disease (PD): ≥25% increase in contrast enhancement for any measurable lesions or definite worsening for any non-measurable lesions, or any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded. Stable Disease (SD): All other situations.
Outcome measures
| Measure |
Temozolomide + Radiation
n=47 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=52 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Objective Tumor Assessment After Surgery: Overall Response
CR
|
1 participants
|
0 participants
|
|
Objective Tumor Assessment After Surgery: Overall Response
PR
|
0 participants
|
0 participants
|
|
Objective Tumor Assessment After Surgery: Overall Response
SD
|
38 participants
|
47 participants
|
|
Objective Tumor Assessment After Surgery: Overall Response
PD
|
3 participants
|
4 participants
|
|
Objective Tumor Assessment After Surgery: Overall Response
No overall response data available
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5.
MGMT was measured by immunohistochemistry (IHC). OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=15 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=20 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group
|
14.4 months
Standard Deviation 2.385
|
17.49 months
Standard Deviation 1.491
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4.
MGMT was measured by IHC. OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=27 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=28 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group
|
13.81 months
Standard Deviation 1.417
|
15.12 months
Standard Deviation 1.171
|
SECONDARY outcome
Timeframe: 6, 12, & 18 monthsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7.
MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=15 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=20 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group
12 months
|
69.3 percentage of participants
Interval 31.2 to 89.1
|
82.8 percentage of participants
Interval 55.4 to 94.2
|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group
18 months
|
36.9 percentage of participants
Interval 6.5 to 69.6
|
66.2 percentage of participants
Interval 35.7 to 84.8
|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group
6 months
|
80.8 percentage of participants
Interval 42.3 to 94.9
|
89.2 percentage of participants
Interval 63.1 to 97.2
|
SECONDARY outcome
Timeframe: 6, 12, & 18 monthsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6.
MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=27 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=28 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group
6 months
|
87.5 percentage of participants
Interval 66.1 to 95.8
|
95.8 percentage of participants
Interval 73.9 to 99.4
|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group
12 months
|
57.7 percentage of participants
Interval 31.9 to 76.8
|
81.4 percentage of participants
Interval 57.5 to 92.6
|
|
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group
18 months
|
44.9 percentage of participants
Interval 21.1 to 66.3
|
26.7 percentage of participants
Interval 9.1 to 48.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9.
MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=15 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=20 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group
|
10.04 months
Standard Deviation 2.094
|
11.19 months
Standard Deviation 1.882
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants with enough tissue to perform MGMT analysis. Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8.
MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide + Radiation
n=27 Participants
Standard therapy regimen:
Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide + Radiation
n=28 Participants
Early postsurgery temozolomide chemotherapy plus standard regimen:
Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).
Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group
|
11.11 months
Standard Deviation 1.441
|
10.46 months
Standard Deviation 1.475
|
Adverse Events
Temozolomide Radiation
Serious events: 11 serious events
Other events: 24 other events
Deaths: 0 deaths
Temozolomide Alone, Then Temozolomide Radiation
Serious events: 11 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide Radiation
n=42 participants at risk
Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide Radiation
n=52 participants at risk
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
Gastrointestinal disorders
VOMITING
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
General disorders
DISEASE PROGRESSION
|
7.1%
3/42 • Number of events 3
Population is all treated participants.
|
3.8%
2/52 • Number of events 2
Population is all treated participants.
|
|
General disorders
DISEASE RECURRENCE
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
Infections and infestations
CENTRAL NERVOUS SYSTEM INFECTION
|
0.00%
0/42
Population is all treated participants.
|
1.9%
1/52 • Number of events 1
Population is all treated participants.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/42
Population is all treated participants.
|
1.9%
1/52 • Number of events 1
Population is all treated participants.
|
|
Injury, poisoning and procedural complications
BRAIN HERNIATION
|
0.00%
0/42
Population is all treated participants.
|
1.9%
1/52 • Number of events 1
Population is all treated participants.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/42
Population is all treated participants.
|
1.9%
1/52 • Number of events 1
Population is all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM RECURRENCE
|
9.5%
4/42 • Number of events 4
Population is all treated participants.
|
9.6%
5/52 • Number of events 6
Population is all treated participants.
|
|
Nervous system disorders
EPILEPSY
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
Nervous system disorders
HEADACHE
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
1.9%
1/52 • Number of events 1
Population is all treated participants.
|
Other adverse events
| Measure |
Temozolomide Radiation
n=42 participants at risk
Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
Temozolomide Alone, Then Temozolomide Radiation
n=52 participants at risk
Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/42
Population is all treated participants.
|
5.8%
3/52 • Number of events 5
Population is all treated participants.
|
|
Gastrointestinal disorders
NAUSEA
|
31.0%
13/42 • Number of events 26
Population is all treated participants.
|
13.5%
7/52 • Number of events 8
Population is all treated participants.
|
|
Gastrointestinal disorders
VOMITING
|
28.6%
12/42 • Number of events 15
Population is all treated participants.
|
7.7%
4/52 • Number of events 4
Population is all treated participants.
|
|
General disorders
GAIT DISTURBANCE
|
7.1%
3/42 • Number of events 3
Population is all treated participants.
|
0.00%
0/52
Population is all treated participants.
|
|
General disorders
PYREXIA
|
11.9%
5/42 • Number of events 5
Population is all treated participants.
|
5.8%
3/52 • Number of events 3
Population is all treated participants.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.5%
4/42 • Number of events 4
Population is all treated participants.
|
3.8%
2/52 • Number of events 2
Population is all treated participants.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/42
Population is all treated participants.
|
7.7%
4/52 • Number of events 4
Population is all treated participants.
|
|
Nervous system disorders
EPILEPSY
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
7.7%
4/52 • Number of events 5
Population is all treated participants.
|
|
Nervous system disorders
HEADACHE
|
23.8%
10/42 • Number of events 12
Population is all treated participants.
|
3.8%
2/52 • Number of events 2
Population is all treated participants.
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.00%
0/42
Population is all treated participants.
|
5.8%
3/52 • Number of events 7
Population is all treated participants.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
2.4%
1/42 • Number of events 1
Population is all treated participants.
|
5.8%
3/52 • Number of events 3
Population is all treated participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Principal Investigator (PI) have the right to publish/present study results. PI and Institution agree not to publish/present any interim study results. PI and Institution further agree to provide 30 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication which report any study results. Sponsor shall have the right to review and comment on any Public Presentation.
- Publication restrictions are in place
Restriction type: OTHER