NCT01125995CompletedPhase 3
A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 222
- Locations
- 2
- Primary Endpoint
- complete response rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
late CCRT
Active Comparator
radiotherapy start on day one of the third cycle of chemotherapy
Intervention: late CCRT (Radiation)
Early CCRT
Experimental
Radiotherapy start on day 1 of 1st cycle of chemotherapy
Intervention: early CCRT (Radiation)
Outcomes
Primary Outcomes
complete response rate
Time Frame: 6 months
Secondary Outcomes
- overall survival(36 months)
- objective response rate(6 months)
- Progression-free survival(36 months)
- toxicity by NCI common toxicity version 2.0(36 months)
Investigators
Keunchil Park
Professor
Samsung Medical Center
Study Sites (2)
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