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Trial of Hypofractionated Radiation Therapy for Glioblastoma

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ClinicalTrials.gov Identifier: NCT02206230
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : January 5, 2016
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
This study is being done to compare standard radiation therapy with hypofractionated radiation therapy for patients with newly diagnosed glioblastoma

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: Hypofractionated radiation therapy Radiation: Standard radiation therapy Phase 2

Detailed Description:
Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 - 70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the length of the radiation course required for these patients with limited survival. The importance of hypofractionation is, therefore, not in improving survival, but rather to shorten RT duration to improve patient comfort and convenience. This approach is pertinent given the limited life expectancy of glioblastoma and has been used in patients with prolonged survival including breast and prostate cancers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma
Study Start Date : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypofractionated radiation therapy
Hypofractionated radiation therapy of 60 Gy in 20 fractions (3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
Radiation: Hypofractionated radiation therapy
Active Comparator: Standard radiation therapy
Standard radiation therapy of 60 Gy in 30 fractions (2 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 4-week break, temozolomide days 1-5 every 28 days for 6 cycles.
Radiation: Standard radiation therapy



Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 24 months from date of randomization to date of death due to any cause ]
    Patients without an event will be censored the last time they were known to be alive


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 24 month where PFS is defined as the time between randomization and radiographic progression based on RECIST criteria or death due to any cause. ]
    Patients without an event will be assessed at the date of last follow-up for progression. Patients with no post-baseline follow-up for progression will be censored at the day of randomization.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, histologically proven intracranial glioblastoma or gliosarcoma
  • History and physical exam within 14 days prior to randomization
  • Between 18 and 70 years of age
  • ECOG 0 - 2
  • Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization

Exclusion Criteria:

  • Prior invasive malignancy unless disease free for > 3 years
  • Prior head or neck RT (except for glottic cancer) or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
  • Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study
  • Specific severe, active co-morbidities
  • Not willing or able to use medically acceptable forms of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206230


Contacts
Contact: Samir Patel, MD 780-432-8783 samir.patel2@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Samir Patel, MD    780-432-8518    samir.patel2@albertahealthservices.ca   
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: Samir Patel, MD Cross Cancer Institute

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02206230     History of Changes
Other Study ID Numbers: BR-02-1401
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: December 2015

Keywords provided by AHS Cancer Control Alberta:
glioblastoma
radiotherapy
hypofractionated radiotherapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents