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Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer



Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer

For Condition: limited stage small cell lung cancer,extensive stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): Massey Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BrianKavanagh,  Study Chair,  Massey Cancer Center

Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 


Additional Information:
Study ID Numbers:  CDR0000068152;  MCV-MCC-9912-2A,NCI-V00-1613
Study Start Date: May 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006344

Other Limited Stage Small Cell Lung Cancer Studies:
1. Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

2. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

3. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment

4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.

5. Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer

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Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
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