A Phase III Study of Re-Irradiation in Recurrent Glioblastoma

NCT01830101 | Withdrawn Phase 3 DMC

• 1 other identifier: CCI-Patel-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Glioblastoma

Keywords

recurrent glioblastoma; re-irradiation; continuous low-dose temozolomide

Outcome Measures

Primary Outcomes (1)

• To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.

  2 months

Secondary Outcomes (1)

• To evaluate time to radiographic progression or recurrence of tumour following treatment with continuous dose-intense temozolomide with or without re-irradiation.

  2 months

Study Arms (2)

TMZ plus concurrent re-irradiation

EXPERIMENTAL

TMZ plus concurrent re-irradiation

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

TMZ alone

EXPERIMENTAL

TMZ alone

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

Interventions

TMZ plus concurrent re-irradiation DRUG

Also known as: Temedol

TMZ alone; TMZ plus concurrent re-irradiation

Temozolomide DRUG

low-dose temozolomide daily for one year

Also known as: Temedol

TMZ alone; TMZ plus concurrent re-irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• tumour progression or recurrence within 3 months of initial concurrent chemoradiation
• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Samir Patel, MD

  Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

• Gerald Lim, MD

  Tom Baker Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 12, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2017
• Last Updated: March 16, 2016

Record last verified: 2014-02

Locations

CA (1)