S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic radiosurgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) Metastatic Cancer |
Radiation: stereotactic radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases |
| Enrollment: | 2 |
| Study Start Date: | July 1999 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Estimate the 6 month intracranial progression rate and 6 month overall survival rate in patients with limited brain metastases from malignant melanoma undergoing whole brain radiotherapy followed by stereotactic radiosurgery boost. II. Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5 weeks later by stereotactic radiosurgery. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven malignant melanoma at primary or any metastatic site Bidimensionally measurable disease by MRI scan Must have 1-6 enhancing brain metastases If at least 2 lesions are present, only 1 lesion may be greater than 3 cm in maximum diameter
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier or immunotherapy Chemotherapy: No concurrent chemotherapy with whole brain radiotherapy Prior systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior stereotactic or conventional radiotherapy to any field of the brain Surgery: Prior surgical resection of brain metastases allowed (provided 1 or 2 measurable brain metastases remain)
Contacts and Locations
Show 86 Study Locations| Study Chair: | James G. Douglas, MD | University of Washington |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003911 History of Changes |
| Other Study ID Numbers: | CDR0000067090, S9903, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage IV melanoma recurrent melanoma tumors metastatic to brain |
Additional relevant MeSH terms:
|
Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013