Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

NCT00003308 | Completed Phase 2

• 2 other identifiers: CDR0000066255E-6397
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 14

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.

Conditions

Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma

Keywords

metastatic osteosarcoma; chondrosarcoma; stage IV renal cell cancer; stage IV melanoma; tumors metastatic to brain; stage IV uterine sarcoma; ovarian sarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma

Interventions

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients have a medical contraindication to MRI) * No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter * No limitation on the extent of extracranial metastatic disease * No metastases in the brain stem, midbrain, pons, or medulla * No leptomeningeal metastases documented by MRI or CSF evaluation * No metastases within 10 mm of optic nerve or chiasm * No history of multiple liver metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No major medical illness * No psychoses * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed * Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery Endocrine therapy: * Not specified Radiotherapy: * No prior cranial radiotherapy * Prior or concurrent radiotherapy to noncranial sites allowed Surgery: * No prior surgical resection for brain metastases * Prior stereotactic biopsy for diagnostic purposes allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (14)

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Alegent Health-Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

Related Publications (1)

• Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group. Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6. doi: 10.1200/JCO.2005.01.8747.

  PMID: 16314647 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Neoplasm Metastasis; Ovarian Neoplasms; Sarcoma; Osteosarcoma; Chondrosarcoma; Carcinoma, Renal Cell; Brain Neoplasms; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Minesh P. Mehta, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 2, 1999
• Primary Completion: September 1, 2004
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (11); AU (1); PR (1); PE (1)