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Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
Not Recruiting
Trial ID: NCT00048997
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
known if giving radiation therapy to the head is effective in preventing CNS metastases in
patients who have stage III non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head
works in preventing CNS metastases in patients who have been previously treated for stage III
non-small cell lung cancer.
Official Title
A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
Stanford Investigator(s)
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Heather Wakelee
Professor of Medicine (Oncology)
Billy W Loo, Jr, MD PhD FASTRO FACR
Professor of Radiation Oncology (Radiation Therapy)
Eligibility
DISEASE CHARACTERISTICS:
- Diagnosis of stage IIIA or IIIB non-small cell lung cancer
- Complete response, partial response, or stable disease after definitive
locoregional therapy (with surgery and/or radiation therapy, with or without
chemotherapy (chemotherapy alone does not constitute definitive therapy))
- No more than 16 weeks since prior therapy
- No progressive disease
- No extracranial distant metastatic disease
- No suspicion of CNS metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No other malignancy within the past 3 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biologic therapy
Chemotherapy
- See Disease Characteristics
- No concurrent anticancer cytotoxic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior cranial irradiation
Surgery
- See Disease Characteristics
Other
- Recovered from all prior therapies
- No concurrent enrollment on any other phase III study that has progression-free,
disease-free, or overall survival as an endpoint
Intervention(s):
radiation: radiation therapy
other: Observation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Derek Huang
6507250203