A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Dacarbazine; Temozolomide

Criteria

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