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Home > "A" Clinical Trials Conditions > Adjuvant Radiation Therapy in Treating Patients With Brain Metastases  Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
For Condition: brain metastases
Status: Recruiting
Sponsor(s): EORTC Radiotherapy Cooperative Group , EORTC Brain Tumor Cooperative Group
Synopsis: 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: Randomizedphase III trial to study the effectiveness of whole-brain radiation therapy after surgery or radiosurgery in treating patients with brain metastases from solid tumors.
Details: OBJECTIVES: - 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. - Assess survival, performance status, freedom from intracranial relapse, acute and late side effects, and quality of life in 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 prior treatment (surgical resection vs radiosurgery). - Arm I: Patients undergo adjuvant whole brain radiotherapy. - Arm II: Patients do not receive adjuvant radiotherapy. Patients are followed at 8 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Meets 1 of the following criteria: - Stable systemic cancer for the last 3 months (absence of symptomatic or radiological progression) - Asymptomatic synchronous primary tumor - One to three brain lesions required - No brain stem metastases - Largest diameter less than 3.5 cm for single metastasis - Largest diameter less then 2.5 cm for multiple metastases - Prior radiosurgery patients must meet the following criteria: - Brain metastases from a histologically confirmed primary or metastatic extracranial tumor - Stereotactic biopsy required if not extracranial tumor (carcinoma of unknown provenance) OR extracranial diagnosis made more than 4 years previously - No brain metastases from small cell lung cancer, lymphoma, or teratoma - Prior neurosurgery patients must have undergone complete surgical resection PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 (may be assessed under steroid therapy) Life expectancy - More than 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No chemotherapy from 2 weeks prior to study entry until 6 weeks after brain irradiation Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the brain Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Rolf-PeterMueller, , Medizinische Universitaetsklinik I
Universita Degli Studi di Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Contact Person 39-11-663-6327
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-2-477-6040
Centre Haute Energie *Recruiting*
Nice, , 6000
France
Recruiting Contact Person 33-493-53-8700
Institut Catala d'Oncologia - Hospital Duran i Reynals *Recruiting*
Barcelona, , 08907
Spain
Recruiting Contact Person 34-3-2607820
Rambam Medical Center *Recruiting*
Haifa, , 31096
Israel
Recruiting Contact Person 972-4-854-3013
Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln *Recruiting*
Koln, , D-50924
Germany
Recruiting Contact Person 49-221-478-4400
Ospedale Gyneco Sta. Anna *Recruiting*
Torino, , 10126
Italy
Recruiting Contact Person 39-11-313-5230
Centre Leon Berard *Recruiting*
Lyon, , 69008
France
Recruiting Contact Person 33-478-782-828
Hospital Santa Maria *Recruiting*
Lisbon, , 1699
Portugal
Recruiting Contact Person 351-1-780-5000
Universitaetsklinikum Tuebingen *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Contact Person 49-0-7071-290
CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon, , 25030
France
Recruiting Contact Person 33-3-8166-8166
Ospedale San Giovanni *Recruiting*
Bellinzona, , CH-6500
Switzerland
Recruiting Contact Person 41-811-9111
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Contact Person 33-492-031-000
Ospedale Mauriziano Umberto I *Recruiting*
Torino, , 10128
Italy
Recruiting Contact Person 39-11-508-1111
Radiotherapeutisch Instituut Limburg-Maastricht *Recruiting*
Maastricht, , NL-6229 ET
Netherlands
Recruiting Contact Person 31-43-387-4461
Istituto Nazionale Neurologico "Carlo Besta" *Recruiting*
Milano, , 20133
Italy
Recruiting Contact Person 39-2-23941
Centre Hospitalier Regional et Universitaire de Lille *Recruiting*
Lille, , 59037
France
Recruiting Contact Person 33-320-444-255
Marmara University Hospital *Recruiting*
Istanbul, , 81190
Turkey
Recruiting Contact Person 90-216-327-5050
Additional Information:
Study ID Numbers: CDR0000065229; EORTC-22952,EORTC-26001
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002899
Other Brain Metastases Studies:
1. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
2. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
3. Temozolomide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
4. Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
5. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
Related Studies:
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Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
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