Short Course Chemo-Radiation Therapy for Newly Diagnosed Glioblastoma Patients

Sponsor: John Flickinger

Sponsor score: 0

ClinicalTrials ID:NCT04019262

Provider View

This study is testing two different short-course radiation schedules combined with the chemotherapy drug temozolomide to treat patients with newly diagnosed glioblastoma, a type of brain cancer.

Patient Parameters

Program Overview

This clinical trial is exploring two different short-course radiation therapy schedules combined with the chemotherapy drug temozolomide for treating glioblastoma, a type of aggressive brain cancer. The study aims to find out which radiation schedule is more effective when used alongside temozolomide.

Description

In this study, all patients will receive standard care with short-course radiation therapy and temozolomide (TMZ) chemotherapy pills.

The treatment is divided into three phases: Chemo-radiation Phase, Adjuvant Phase, and Follow-Up Phase.

Before starting the Chemo-radiation Phase, patients will have an MRI scan to assess the tumor.

Chemo-radiation Phase: Patients will be assigned to either a one-week or three-week treatment group. Radiation treatments will be given about 5 days a week, and patients will take TMZ pills once a day, including weekends, starting the day they begin radiation. After finishing radiation, there will be a 4-week break before the next phase.

Radiation Therapy: Patients will receive either 40 Gy in 15 sessions or 25 Gy in 5 sessions, along with temozolomide chemotherapy. The radiation will target the tumor and surrounding brain tissue.

Adjuvant Phase: Patients will receive monthly cycles of TMZ chemotherapy for up to a year.

Follow-Up Phase: Patients will have regular check-ups to monitor their health and the effectiveness of the treatment. These visits will be similar to what they would normally have if not in the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Diagnosed with WHO Grade IV Glioblastoma before starting radiation.
  • Have not received prior radiation of 50Gy or more.
  • No signs of cancer spread to other parts of the body.
  • Must have baseline lab tests showing adequate blood counts and organ function.
  • Women must not be pregnant and must have a negative pregnancy test before starting the study.
  • Must have a baseline MRI scan to assess the tumor.
  • Must have a Karnofsky Performance Status below 60 or ECOG score of 3 or 4.
  • Any previous chemotherapy is allowed.

Exclusion Criteria

  • Evidence of cancer spread to other parts of the body.
  • Women who are breastfeeding or have a positive pregnancy test.
  • Any severe health condition that would prevent full participation in the study.
  • Karnofsky Performance Status less than 50.
  • Previous radiation to the brain area involved in the study.

Locations

FACILITYZIPCITYSTATE
University of Pittsburgh Medical Center, Radiation Oncology15232PittsburghPennsylvania

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