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ACTIVE NOT RECRUITING
NCT02177578
PHASE2

Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

In this study patients will be treated with 6 weeks of radiation therapy plus temozolomide chemotherapy according to the standard of care. However, the radiation treatment plan will be modified to deliver an higher than routine radiation dose to the subventricular zone which is an area of the brain that contains stem cells that some scientists believe may contribute to glioblastoma recurrence. The purpose of the study is to see if the tumor is controlled for a longer period of time in patients treated with this modified radiation technique than it is in patients treated with standard radiation therapy plus temozolomide chemotherapy.

Official title: A Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma Multiforme

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2014-07-08

Completion Date

2027-06

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DRUG

Temozolomide

Patients will be scheduled to receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle).

RADIATION

Subventricular Zone radiation

Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows: Initial treatment plan: Will be prescribed to 46 Gy in 2 Gy fractions Cone down treatment plan: Will be prescribed to 14 Gy in 2 Gy fractions

RADIATION

Neural Progenitor Cell Sparing radiation

Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows: Initial treatment plan: Will be prescribed to 46 Gy in 2 Gy fractions Cone down treatment plan: Will be prescribed to 14 Gy in 2 Gy fractions

Locations (3)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

The SKCCC at Johns Hopkins

Baltimore, Maryland, United States

Suburban Hospital

Bethesda, Maryland, United States