Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
Key facts
- Where
- Almería, Barakaldo, Girona, Las Palmas de Gran Canaria, Madrid, Murcia, Salamanca, Santander, Santiago de Compostela, Seville, and Valencia, SpainSee the 13 sites
- Phase
- Phase 3
Where in Spain
- Hospital Universitario de TorrecardenasAlmería, SpainNot yet recruiting
- Hospital Universitario de CrucesBarakaldo, SpainNot yet recruiting
- Instituto Catalán de OncologíaGirona, SpainNot yet recruiting
- Hospital Dr. NegrínLas Palmas de Gran Canaria, SpainNot yet recruiting
- Hospital Gregorio MarañonMadrid, SpainNot yet recruiting
- Hospital Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Virgen de ArrixacaMurcia, SpainNot yet recruiting
- Complejo Asistencial Universitario de SalamancaSalamanca, SpainTaking people
- Hospital Marques de ValdecillaSantander, SpainNot yet recruiting
- Complejo Hospitalario Universitario de SantiagoSantiago de Compostela, SpainNot yet recruiting
- Genesis CareSeville, SpainNot yet recruiting
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
- Hospital La FeValencia, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación Biomédica de Salamanca
- Trial code
- NCT07015892
- Record updated
- 31 March 2026
- Original description
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.Read full original descriptionShow less
Phase III Randomized Clinical Trial to Evaluate the Efficacy and Safety of Twice-Daily Hyperfractionated Dose-Escalated Thoracic Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (ESCALADOR Study)
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
Inclusion: 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: 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.