Hypofractionated Radiation Therapy for Glioblastoma

Phase 2

• Conditions: Glioblastoma Multiforme
• Interventions: Radiation: Hypofractionated radiation therapy

• Registration Number: NCT03212235
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-05
• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2019-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	24 months	From date of the start of treatment to date of death due to any cause.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP; 🇧🇷 São Paulo, Sao Paulo, Brazil