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A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma

Thank you

Trial Information

A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma


- 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

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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months


- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 50,000/mm^3

- Hemoglobin greater than 8 g/dL


- Not specified


- Not specified


- No major medical illness

- No psychoses

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- Prior chemotherapy allowed

- Systemic chemotherapy may be continued at the discretion of investigator after
completion of radiosurgery

Endocrine therapy:

- Not specified


- No prior cranial radiotherapy

- Prior or concurrent radiotherapy to noncranial sites allowed


- No prior surgical resection for brain metastases

- Prior stereotactic biopsy for diagnostic purposes allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Minesh P. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • Ovarian Cancer
  • Sarcoma
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms
  • Sarcoma



Ireland Cancer Center Cleveland, Ohio  44106-5065
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Iowa Methodist Medical Center Des Moines, Iowa  50309
Mercy Medical Center Des Moines, Iowa  50314
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Alegent Health-Midlands Community Hospital Papillion, Nebraska  68128-4157