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

Recruiting now · Phase 3

Conditions studied: Small Cell Lung Carcinoma

In brief

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

Key facts

Study ID

NCT07015892

Run by

Instituto de Investigación Biomédica de Salamanca

People needed

300

Starts

2026-03-01

Expected to finish

2028-12-31

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Complejo Asistencial Universitario de Salamanca — Salamanca, Salamanca, Spain (enrolling)
• Hospital Ramon y Cajal — Madrid, Spain (enrolling)
• Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
• Instituto Catalán de Oncología — Girona, Spain
• Hospital Dr. Negrin — Las Palmas de Gran Canaria, Spain
• Hospital Gregorio Marañon — Madrid, Spain
• Hospital La Fe — Valencia, Spain
• Hospital Universitario Virgen de Arrixaca — Murcia, Spain
• Hospital Marques de Valdecilla — Santander, Spain
• Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain
• Genesis Care — Seville, Spain
• Hospital Universitario de Torrecardenas — Almería, Spain
• Hospital Universitario de Cruces — Barakaldo, Spain

Full record on ClinicalTrials.gov

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