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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
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Minesh P. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000066255

NCT ID:

NCT00003308

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

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Medical CenterDes Moines, Iowa  50314
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Alegent Health-Midlands Community HospitalPapillion, Nebraska  68128-4157