Study Comparing Two Types of Radiation Therapy for Patients with Brain Cancer Spread from Other Parts of the Body

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0

ClinicalTrials ID:NCT04114981

This clinical trial is exploring whether a single high-dose radiation treatment or multiple smaller doses of radiation are more effective for patients whose brain cancer has been surgically removed. The study aims to determine which method better prevents cancer from returning and improves patients' quality of life.

Patient Parameters

Program Overview

This study is investigating two different radiation treatments for patients who have had brain cancer spread from other parts of the body and have undergone surgery to remove it. The trial compares single fraction stereotactic radiosurgery (a one-time high-dose radiation) with fractionated stereotactic radiosurgery (multiple smaller doses over time) to see which is more effective in preventing cancer from returning and improving patients' quality of life.

Description

The main goal of this study is to find out if giving multiple smaller doses of radiation (fractionated stereotactic radiosurgery or FSRS) is better at preventing cancer from coming back in the area where it was removed compared to a single high-dose treatment (single-fraction stereotactic radiosurgery or SSRS).

Other goals include:

  • Checking if patients feel better emotionally and have a better quality of life with FSRS compared to SSRS.
  • Seeing if patients live longer with FSRS.
  • Comparing how independent patients are after each treatment.
  • Looking at side effects and how they might be affected by other treatments like immunotherapy.
  • Checking for differences in radiation-related brain damage and cancer spread patterns.
  • Evaluating if FSRS delays the need for whole-brain radiation therapy.
  • Assessing long-term survivors for emotional well-being and quality of life.
  • Exploring differences in cognitive function and quality of life with FSRS.

Participants will be randomly assigned to one of two groups: one receiving SSRS in one session, and the other receiving FSRS over three or five sessions. Follow-up visits will occur at various intervals up to five years after treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have had brain cancer that spread from another part of the body and was removed by surgery.
  • Can have up to three small brain tumors that haven't been removed.
  • Tumors must be less than 4 cm in size.
  • One tumor must have been completely removed within 30 days before joining the study.
  • Must be able to have an MRI scan with contrast.
  • Must not have had whole-brain radiation therapy before.
  • Must not have certain types of cancer like germ cell tumors, small cell carcinoma, or lymphoma.
  • Must not have cancer spread to the brain's protective layers (leptomeningeal metastasis).
  • Must be able to speak English, Spanish, or French.
  • Must complete quality of life and cognitive assessments before starting the study.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Cancer Center35233BirminghamAlabama
Anchorage Radiation Therapy Center99504AnchorageAlaska
Banner MD Anderson Cancer Center85234GilbertArizona
Banner Thunderbird Medical Center85306GlendaleArizona
Banner-University Medical Center Phoenix85006PhoenixArizona
Mayo Clinic Hospital in Arizona85054PhoenixArizona
Mayo Clinic in Arizona85259ScottsdaleArizona
University of Arizona Cancer Center-North Campus85719TucsonArizona
Mercy Hospital Fort Smith72903Fort SmithArkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro72401JonesboroArkansas

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