Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

Phase 3TerminatedNCT00002899

European Organisation for Research and Treatment of Cancer - EORTC340 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

340

Conditions

Metastatic Cancer

Interventions

adjuvant therapyPROCEDURE

radiation therapyRADIATION

stereotactic radiosurgeryRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of brain metastases from a histologically confirmed primary or metastatic extracranial tumor, meeting 1 of the following criteria: * Stable systemic cancer for the last 3 months (achieved by surgery, radiotherapy, chemotherapy, or hormonal therapy), defined as absence of symptomatic or radiological progression * Asymptomatic synchronous primary tumor (treatable by surgery, radiotherapy, chemotherapy, or hormonal therapy) * No metastases outside the CNS * Unknown primary tumor * Must have one to three brain lesions, confirmed by enhanced MRI prior to radiosurgery or surgery * No brain stem metastases * No leptomeningeal metastases * No brain metastases from small cell lung cancer, lymphoma, leukemia, myeloma, or germ cell tumors * Patients planning to undergo radiosurgery must meet the following criteria: * Largest diameter ≤ 3.5 cm for single metastasis * Largest diameter ≤ 2.5 cm for multiple metastases * Stereotactic biopsy required if not extracranial tumor (unknown primary tumor) OR extracranial diagnosis made more than 4 years previously * Prior neurosurgery patients must have undergone complete surgical resection * No recurrent brain metastases after prior surgery and/or radiosurgery and/or brain radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 (may be assessed under steroid therapy) Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No concurrent chemotherapy during whole brain radiotherapy Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics

Locations (33)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, Belgium

U.Z. Gasthuisberg

Leuven, Belgium

Algemeen Ziekenhuis Sint-Augustinus

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Helsinki University Central Hospital

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Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

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Centre Hospitalier Regional et Universitaire de Lille

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Centre Antoine Lacassagne

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Centre Haute Energie

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...and 23 more locations