Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.

Official Title
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A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: early CCRT
* Radiation: late CCRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed small-cell lung cancer limited disease status with evaluable disease 18 years or older ECOG performance status 0,1,2 expected survival time should be 12 weeks or longer Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min Written informed consent form Exclusion Criteria: Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia Patients with active infection requiring antibiotics Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method) Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer previous history of chemotherapy or radiotherapy

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: late CCRT<br>radiotherapy start on day one of the third cycle of chemotherapy | Radiation: late CCRT<br>* patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).<br>|
| Experimental: Early CCRT<br>Radiotherapy start on day 1 of 1st cycle of chemotherapy | Radiation: early CCRT<br>* patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 36 months | 
| objective response rate |  | 6 months | 
| Progression-free survival |  | 36 months | 
| toxicity by NCI common toxicity version 2.0 |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limited disease