Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Procedure: adjuvant therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases |
- 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 [ Designated as safety issue: No ]
- Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
- Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
- Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
- Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 340 |
| Study Start Date: | November 1996 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 33 Study Locations| Study Chair: | Rolf-Peter Mueller, MD | Medizinische Universitaetsklinik I at the University of Cologne |
| Study Chair: | Riccardo Soffietti, MD | Universita Degli Studi di Turin |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002899 History of Changes |
| Other Study ID Numbers: | EORTC-22952-26001, EORTC-22952, EORTC-26001 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
tumors metastatic to brain |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013