Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over Other EORTC-22952 EORTC-26001, NCT00002899

Objectives

Primary

1. 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

1. Determine overall survival and progression-free survival of patients treated on this protocol.
2. Determine time to neurologic progression in patients treated on this protocol.
3. Determine quality of life of patients treated on this protocol.

Entry 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

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

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

Expected Enrollment

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

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

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

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Rolf-Peter Mueller, MD, Study coordinator		Ph: 49-221-478-5450
Riccardo Soffietti, MD, Study coordinator		Ph: 39-011-633-4904 Email: riccardo.soffietti@unito.it

Registry Information
Official Title		Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
Trial Start Date		1996-11-06
Registered in ClinicalTrials.gov		NCT00002899
Date Submitted to PDQ		1996-11-06
Information Last Verified		2007-10-07

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