Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

Phase 3

Terminated

• Conditions: Metastatic Cancer

• Registration Number: NCT00002899
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.

PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.

Detailed Description

OBJECTIVES:

Primary

* Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.

Secondary

* Determine overall survival and progression-free survival of patients treated on this protocol.

* Determine time to neurologic progression in patients treated on this protocol.

* Determine quality of life of patients treated on this protocol.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).

Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.

* Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).

* Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.

* Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.

* Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.

After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.

Study Timeline

• Study Start: 1996-11
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death

Secondary Outcome Measures

Name	Time	Method
Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death
Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death

Trial Locations

Locations (33)

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Algemeen Ziekenhuis Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Centre Hospitalier Regional et Universitaire de Lille; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Haute Energie; 🇫🇷 Nice, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

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