Not Signed In -
Non-Small Cell Lung Cancer |
Lung Cancer, Non-Small Cell |
Clinical Trial: Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy may be more effective in preventing brain metastases. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in preventing brain metastases in patients who have small cell lung cancer that has been diagnosed within the past year.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| extensive stage small cell lung cancer limited stage small cell lung cancer | Procedure: Prophylactic cranial irradiation in lung cancer patients | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Prophylactic Cranial Irradiation in Patients With Small Cell Carcinoma of the Lung
Study start: May 2000
OBJECTIVES: I. Compare the efficacy of low dose versus high dose prophylactic cranial irradiation in preventing brain metastases in patients with small cell carcinoma of the lung. II. Determine the neuropsychiatric status of these patients before and after treatment.
PROTOCOL OUTLINE: This is a randomized, multicenter study. The right or left hemisphere of each patient's brain are randomized to one of two treatment arms. All patients receive whole brain radiotherapy 5 days a week over 2.5 weeks for a total of 12 fractions. Arm I: Patients receive radiotherapy to the left cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Arm II: Patients receive radiotherapy to the right cerebral hemisphere daily for 6 days immediately following completion of whole brain radiotherapy. Patients with extensive disease may also receive thoracic radiotherapy, if not administered previously. Patients are followed at 1, 3, 6, 9, and 12 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 16-40 patients will be accrued for this study within 1-4 years.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed small cell carcinoma of the lung diagnosed within the past year; Limited stage; Must have completed prior chemotherapy with thoracic irradiation; Extensive stage; Must have completed prior chemotherapy with or without thoracic irradiation
- No more than 24 Gy of prior prophylactic cranial irradiation to the whole brain
- No brain metastases
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: See Disease Characteristics
- Endocrine therapy: Not specified
- Radiotherapy: See Disease Characteristics
- Surgery: Not specified
--Patient Characteristics--
- Age: Not specified
- Performance status: Karnofsky 50-100%
- Life expectancy: Not specified
- Hematopoietic: Not specified
- Hepatic: Not specified
- Renal: Not specified
- Other: No other prior malignancy within the past 3 years except the following: Adequately treated basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Location Information
Brian Kavanagh, Study Chair, Massey Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: October 4, 2000
ClinicalTrials.gov Identifier: NCT00006344
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Lung Cancer, Non-Small Cell (National Cancer Institute)
- Non-Small Cell Lung Cancer Treatment (National Cancer Institute)
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