Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
18 Years
N/A
Both
Metastatic Cancer
Trial Information
Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Rolf-Peter Mueller, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medizinische Universitaetsklinik I at the University of Cologne
Authority:
United States: Federal Government
Study ID:
EORTC-22952-26001
NCT ID:
NCT00002899
Start Date:
November 1996
Completion Date:
Related Keywords:
- Metastatic Cancer
- tumors metastatic to brain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
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