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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125995

Enrollment

222

Registered

2010-05-19

Start date

2003-06-30

Completion date

2013-05-31

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

limited disease

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.

Interventions

RADIATIONlate CCRT

1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy).

RADIATIONearly CCRT

1. patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1. 2. radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
complete response rate	6 months

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026