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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Small Cell Lung Cancer

Treatments: Radiation: late CCRT; Radiation: early CCRT

Study type: Interventional

Funder types: Other

Identifiers

NCT01125995

2003-02-016

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

late CCRT

Active Comparator group

Description:

radiotherapy start on day one of the third cycle of chemotherapy

Treatment:

Radiation: late CCRT

Early CCRT

Experimental group

Description:

Radiotherapy start on day 1 of 1st cycle of chemotherapy

Treatment:

Radiation: early CCRT