Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Rolf-Peter Mueller

Riccardo Soffietti

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002899
Information obtained from ClinicalTrials.gov on January 10, 2012

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