Hypofractionated Radiation Therapy for Glioblastoma

Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.

Study Overview

• Status: Unknown
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Radiation: Hypofractionated radiation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01246-000
      • Recruiting
      • Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP
      • Contact: Gustavo N Marta, PhD; Phone Number: 55+11+38934538; Email: gustavo.marta@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
• WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

• Prior diagnosis of cancer, unless disease free for > 3 years
• Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
• Specific severe, active co-morbidities
• Tumor located in the brainstem
• Presence of leptomeningeal carcinomatosis
• Multicentric tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated radiation therapy; Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.	Radiation: Hypofractionated radiation therapy; Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From date of the start of treatment to date of death due to any cause.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The time between the start of treatment and tumor progression or death due to any cause.	24 months

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: Hypofractionated GBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No