Hypofractionated Radiation Therapy for Glioblastoma

Glioblastoma Multiforme Clinical Trial

Official title:

Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212235
• Other study ID #: Hypofractionated GBM
• Status: Recruiting
• Phase: Phase 2
• First received: July 5, 2017
• Last updated: July 7, 2017
• Start date: June 5, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2017
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Gustavo N Marta, PhD
• Phone: 551138934538
• Email: gustavo.marta[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Radiation:
• Hypofractionated radiation therapy
Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From date of the start of treatment to date of death due to any cause.	24 months
Secondary	Progression-free survival	The time between the start of treatment and tumor progression or death due to any cause.	24 months