Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy. Compare the quality of life and survival of these patients. Determine the toxicity of this regimen in these patients. Determine the health economics associated with this study. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and performance status. Patients are randomized to 1 of 2 treatment arms. Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days. Arm II: Patients receive no further therapy after completion of prior chemotherapy. Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.

Official Title
-----------------
Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Cytologically or histologically confirmed small cell lung cancer Documented extensive disease before the initiation of chemotherapy Responsive disease after 4 to 6 courses of initial chemotherapy No more than 5 weeks since completion of prior chemotherapy No brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to the brain No prior radiotherapy to the head and neck Surgery: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessed by EORTC QLQ-C30 and EORTC BN-20 at baseline, 6 weeks, every 3 months in year 1, and then every 6 months |  |  | 
| Toxicity assessed by NCI CTC v2.0 during treatment, at 6 weeks, every 3 months in year 1, and then every 6 months |  |  | 
| Survival measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extensive stage small cell lung cancer