Hypofractionated Radiation Therapy for Glioblastoma

Instituto do Cancer do Estado de São Paulo

Status and phase: Unknown; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Radiation: Hypofractionated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03212235

Hypofractionated GBM

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Hypofractionated radiation therapy

Experimental group

Description:

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.

Treatment:

Radiation: Hypofractionated radiation therapy