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

Primary Purpose

Kidney Cancer, Melanoma (Skin), Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
stereotactic radiosurgery
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iowa Methodist Medical Center
  • Mercy Medical Center
  • Iowa Lutheran Hospital
  • CCOP - Kalamazoo
  • Alegent Health-Midlands Community Hospital
  • MBCCOP - University of New Mexico HSC
  • Ireland Cancer Center
  • Milton S. Hershey Medical Center
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • San Juan City Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 21, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003308
Brief Title
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
Official Title
A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 1999 (Actual)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma. Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm). Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression. All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minesh P. Mehta, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Alegent Health-Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16314647
Citation
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.
Results Reference
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Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

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