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Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
Primary Objective:
To determine if dose-intensifying (increasing the dose-density ) the adjuvant
temozolomide component of the chemoradiation treatment enhances treatment
efficacy as measured by overall survival.
Secondary Objectives:
To determine if dose-intensifying the adjuvant temozolomide component of the
chemoradiation treatment enhances treatment efficacy as measured by
progression-free survival.
To determine in patients with unmethylated MGMT if dose-intensifying the
adjuvant temozolomide component of the chemoradiation treatment enhances
treatment efficacy (overall and progression-free survival) compared with patients
receiving conventional temozolomide dosing.
To determine in patients with methylated MGMT if dose-intensifying the adjuvant
temozolomide component of the chemoradiation treatment enhances treatment
efficacy (overall and progression-free survival) compared with patients receiving
conventional temozolomide dosing.
To determine if there is an association between tumor MGMT gene methylation
status and treatment response.
To compare and record the toxicities of the conventional and dose-intense
chemotherapy regimens.
To evaluate whether 6-month progression-free survival is associated with overall
survival.
Net Clinical Benefit Objectives:
Primary:
To compare between the two treatment arms the symptom burden, NCF, and
HRQOL in patients who are without progression after 6 months of adjuvant
therapy (6 month progression-free survival).
To evaluate midcycle differences in symptom burden and HRQOL in patients
on the two arms at day 14 of course 1 and course 4.
Secondary:
To evaluate longitudinal changes in HRQOL measures and determine the
impact of dose-intense chemotherapy on these parameters.
To measure symptom burden and degree of interference over the course of
therapy to evaluate differences between patients individual symptom severity,
overall mean symptom severity, and difference in scores on the interference
items between the two treatment arms.
To describe the association between quality of life as measured by the EORTCQL30/
BCM20 and mean symptom severity as measured by the MDASI-BT in
patients enrolled in this study.
To describe the variability of symptom severity across the epoch and follow-up
period to compare differences between the two treatment arms.
To evaluate these instruments as a useful composite measurement of the
impact of treatment and disease response in analysis of efficacy.
To evaluate differences in longitudinal changes on measures of NCF
associated with dose-intense chemotherapy.
To evaluate the relationship between self-reported cognitive dysfunction and
NCF testing.
Primary Objective:
To determine if dose-intensifying (increasing the dose-density ) the adjuvant
temozolomide component of the chemoradiation treatment enhances treatment
efficacy as measured by overall survival.
Secondary Objectives:
To determine if dose-intensifying the adjuvant temozolomide component of the
chemoradiation treatment enhances treatment efficacy as measured by
progression-free survival.
To determine in patients with unmethylated MGMT if dose-intensifying the
adjuvant temozolomide component of the chemoradiation treatment enhances
treatment efficacy (overall and progression-free survival) compared with patients
receiving conventional temozolomide dosing.
To determine in patients with methylated MGMT if dose-intensifying the adjuvant
temozolomide component of the chemoradiation treatment enhances treatment
efficacy (overall and progression-free survival) compared with patients receiving
conventional temozolomide dosing.
To determine if there is an association between tumor MGMT gene methylation
status and treatment response.
To compare and record the toxicities of the conventional and dose-intense
chemotherapy regimens.
To evaluate whether 6-month progression-free survival is associated with overall
survival.
Net Clinical Benefit Objectives:
Primary:
To compare between the two treatment arms the symptom burden, NCF, and
HRQOL in patients who are without progression after 6 months of adjuvant
therapy (6 month progression-free survival).
To evaluate midcycle differences in symptom burden and HRQOL in patients
on the two arms at day 14 of course 1 and course 4.
Secondary:
To evaluate longitudinal changes in HRQOL measures and determine the
impact of dose-intense chemotherapy on these parameters.
To measure symptom burden and degree of interference over the course of
therapy to evaluate differences between patients individual symptom severity,
overall mean symptom severity, and difference in scores on the interference
items between the two treatment arms.
To describe the association between quality of life as measured by the EORTCQL30/
BCM20 and mean symptom severity as measured by the MDASI-BT in
patients enrolled in this study.
To describe the variability of symptom severity across the epoch and follow-up
period to compare differences between the two treatment arms.
To evaluate these instruments as a useful composite measurement of the
impact of treatment and disease response in analysis of efficacy.
To evaluate differences in longitudinal changes on measures of NCF
associated with dose-intense chemotherapy.
To evaluate the relationship between self-reported cognitive dysfunction and
NCF testing.
Recruitment Status
Past Studies