Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

Detailed Description
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The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.

Official Title
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A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer

Conditions
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Lung Neoplasm, Small Cell Carcinoma

Intervention / Treatment
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* Radiation: Hypofractionated Chest Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: limited stage small cell lung cancer adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%) signed study consent age at least 18 years Karnofsky performance status as least 70% eligible to receive standard concurrent small cell cancer chemotherapy Exclusion Criteria: extensive stage disease mixed non small cell and small cell histology inadequate pulmonary function tests not eligible for concurrent chemotherapy subtotal or total tumor resection previous chest/neck radiotherapy prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years pregnant prior chemotherapy for another malignancy patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Hypofractionated Chest Radiotherapy|Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival |  | 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 2011 | 
| Patterns of Failure |  | 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small cell lung cancer, radiotherapy dose escalation