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

Launched by INSTITUTO DE INVESTIGACIÓN BIOMÉDICA DE SALAMANCA · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat limited-stage small cell lung cancer (SCLC) by increasing the dose of radiotherapy given to patients who are already receiving standard chemotherapy. The goal is to find out if this higher dose, given twice a day, can help patients live longer without their cancer getting worse. Participants will be randomly assigned to different treatment plans to see which one is most effective, while also keeping track of side effects and how the treatments affect their quality of life.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with limited-stage SCLC that hasn't spread. They should not have received prior radiation therapy for lung cancer and must meet other health criteria, like having good blood counts and lung function. While the trial is not yet recruiting participants, it aims to improve treatment options for patients with this aggressive type of cancer, potentially leading to better long-term survival rates.

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Eligibility criteria

• 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