Higher-dose twice-daily chest radiotherapy for limited-stage small cell lung cancer
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)
PHASE3 · Instituto de Investigación Biomédica de Salamanca · NCT07015892
This trial will test if higher-dose, twice-daily chest radiotherapy given with standard cisplatin and etoposide helps people with limited-stage small cell lung cancer live longer and delay recurrence.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Biomédica de Salamanca (other) |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Salamanca, Salamanca and 12 other locations) |
| Trial ID | NCT07015892 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed limited-stage (M0) small cell lung cancer who are eligible for definitive thoracic radiotherapy, have ECOG performance status 0–2, measurable disease, and adequate hematologic, hepatic, renal, and pulmonary function are eligible.
Not a fit: Patients with extensive-stage disease, prior thoracic radiotherapy or lung surgery for cancer, uncontrolled serious comorbidities, or ECOG >2 are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, a higher-dose twice-daily radiotherapy approach could improve progression-free and overall survival for patients with limited-stage SCLC compared with the current standard schedule.
How similar studies have performed: Twice-daily 45 Gy has been established as a standard by prior randomized work, and smaller or nonrandomized studies of dose escalation have shown promising signals but definitive phase III evidence for higher doses is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salamanca, Salamanca and 12 other locations
- Complejo Asistencial Universitario de Salamanca — Salamanca, Salamanca, 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)
- Hospital Dr. Negrin — Las Palmas de Gran Canaria, Spain (NOT_YET_RECRUITING)
- Hospital Gregorio Marañon — Madrid, Spain (NOT_YET_RECRUITING)
- Hospital Ramon y Cajal — Madrid, Spain (RECRUITING)
- Hospital Universitario Virgen de Arrixaca — Murcia, Spain (NOT_YET_RECRUITING)
- Hospital Marques de Valdecilla — Santander, Spain (NOT_YET_RECRUITING)
- Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain (NOT_YET_RECRUITING)
- Genesis Care — Seville, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Virgen del Rocio — Seville, Spain (RECRUITING)
- Hospital La Fe — Valencia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small Cell Lung Carcinoma, Radiotherapy, Chemoradiotherapy, Dose-Response Relationship, Radiation