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

Phase 3

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Radiation: late CCRT; Radiation: early CCRT

• Registration Number: NCT01125995
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2011-07
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

1. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
2. Patients with active infection requiring antibiotics
3. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
4. 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
5. previous history of chemotherapy or radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
late CCRT	late CCRT	radiotherapy start on day one of the third cycle of chemotherapy
Early CCRT	early CCRT	Radiotherapy start on day 1 of 1st cycle of chemotherapy

Primary Outcome Measures

Name	Time	Method
complete response rate	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	36 months
objective response rate	6 months
Progression-free survival	36 months
toxicity by NCI common toxicity version 2.0	36 months

Trial Locations

Locations (2)

Asan Medican Center; 🇰🇷 Seoul, Korea, Republic of

Keunchil Park; 🇰🇷 Seoul, Korea, Republic of