Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial

Summary

This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). All patients will receive standard chemotherapy with cisplatin and etoposide and will be randomly assigned to one of three radiotherapy regimens. The main objective is to determine whether this intensified radiotherapy improves progression-free survival and overall survival. The study will also compare two different dose escalation strategies and assess treatment side effects and patients' quality of life. This research may help identify a more effective treatment approach for patients with limited-stage SCLC and could contribute to improving long-term survival in this aggressive type of cancer

Eligibility

Inclusion Criteria:

* Histologically confirmed diagnosis of small cell lung cancer (SCLC)
* Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy
* Measurable disease according to RECIST 1.1
* Age ≥18 years
* ECOG performance status 0-2
* No prior thoracic radiotherapy
* Signed informed consent
* Adequate hematologic function: WBC ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L
* Adequate liver and renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤1.5×ULN, creatinine normal or CrCl ≥60 mL/min
* Pulmonary function: FEV1 \>1 L or \>30% predicted; DLCO \>30% predicted

Exclusion Criteria:

* Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)
* Presence of malignant cells in pleural or pericardial effusion
* Serious uncontrolled systemic disorders (e.g., active infection, unstable cardiovascular disease)
* Medical, psychological, or social conditions that could interfere with compliance
* Active malignancy other than SCLC (except localized prostate/breast cancer or basal cell carcinoma)
* Refusal or inability to sign informed consent

Conditions3

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