A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

AHS Cancer Control Alberta

Status and phase: Withdrawn; Phase 3

Conditions: Recurrent Glioblastoma

Treatments: Drug: Temozolomide; Drug: TMZ plus concurrent re-irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01830101

CCI-Patel-01

Details and patient eligibility

About

The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.

Full description

This is a stratified study for patients with recurrent intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation presenting radiographic progression or recurrence of tumour. Patients are stratified by extent of resection, time to re-irradiation and re-irradiation volume.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation
• radiographic evidence of tumour progression or recurrence
• 18 years or older
• ECOG 0 - 2
• signed informed consent form

Exclusion criteria

• tumour progression or recurrence within 3 months of initial concurrent chemoradiation
• 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis
• more than one prior course of salvage chemo for recurrent disease
• prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years
• prior head or neck RT except for T1 glottic cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TMZ plus concurrent re-irradiation

Experimental group

Description:

TMZ plus concurrent re-irradiation

Treatment:

Drug: TMZ plus concurrent re-irradiation

Drug: Temozolomide

TMZ alone

Experimental group

Description:

TMZ alone

Treatment:

Drug: TMZ plus concurrent re-irradiation

Drug: Temozolomide