Clinical trial · Interventional
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
NCT01125995CI-TRIAL-00010475completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| early CCRT | Radiation | — | UNRESOLVED |
| late CCRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- late CCRT
- description
- radiotherapy start on day one of the third cycle of chemotherapy
- interventionNames
- Radiation: late CCRT
- type
- EXPERIMENTAL
- label
- Early CCRT
- description
- Radiotherapy start on day 1 of 1st cycle of chemotherapy
- interventionNames
- Radiation: early CCRT
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- 6 months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.