Higher-dose twice-daily chest radiotherapy for limited-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase III trial that compares three twice-daily thoracic radiotherapy regimens given with standard cisplatin and etoposide chemotherapy for limited-stage small cell lung cancer. Patients are randomly assigned to standard-dose 45 Gy BID, escalated-dose 60 Gy BID, or a simultaneous integrated boost to 45–54 Gy BID. Primary endpoints are progression-free survival and overall survival, with secondary endpoints including toxicity, quality of life (EORTC QLQ-C30 and lung modules), and exploratory circulating biomarkers. The multicenter trial plans to enroll about 300 patients across Spanish centers using modern imaging and radiotherapy techniques to improve target accuracy.

Why it matters

Who can join: the full rules

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

Where it's running

• Complejo Asistencial Universitario de Salamanca
  Salamanca, Salamanca, Spain Recruiting
• Hospital Ramon y Cajal
  Madrid, Spain Recruiting
• Hospital Universitario Virgen del Rocio
  Seville, Spain Recruiting
• Hospital Universitario de Torrecardenas
  Almería, Spain Not yet recruiting
• Hospital Universitario de Cruces
  Barakaldo, Spain Not yet recruiting
• Instituto Catalán de Oncología
  Girona, Spain Not yet recruiting

Study contacts

• Principal investigator: Iñigo San Miguel Arregui, MD PhD — Institute of Biomedical Research of Salamanca
• Study coordinator: Iñigo San Miguel Arregui, MD PhD
• Email: isanm@saludcastillayleon.es
• Phone: +34 923291600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.