Find Small Cell Lung Cancer (SCLC) Clinical Trials Near You
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)
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed diagnosis of small cell lung cancer (SCLC)
• Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy
• 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
Locations
Other Locations
Spain
Hospital Universitario de Torrecardenas
NOT_YET_RECRUITING
Almería
Hospital Universitario de Cruces
NOT_YET_RECRUITING
Barakaldo
Instituto Catalán de Oncología
NOT_YET_RECRUITING
Girona
Hospital Dr. Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Gregorio Marañon
NOT_YET_RECRUITING
Madrid
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de Arrixaca
NOT_YET_RECRUITING
Murcia
Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Marques de Valdecilla
NOT_YET_RECRUITING
Santander
Complejo Hospitalario Universitario de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Genesis Care
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital La Fe
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
Iñigo San Miguel Arregui, MD PhD
isanm@saludcastillayleon.es
+34 923291600
Backup
Cristina Cigarral García, MD
ccigarral@usal.es
+34 923291600
Time Frame
Start Date:2026-03-01
Estimated Completion Date:2028-12-31
Participants
Target number of participants:300
Treatments
Active_comparator: Standard Radiotherapy Arm (45 Gy BID)
Patients in this group will receive concurrent chemoradiotherapy consisting of cisplatin and etoposide with standard-dose thoracic radiotherapy: 45 Gy administered in 30 fractions of 1.5 Gy twice daily (BID).
Experimental: Escalated Dose Radiotherapy Arm (60 Gy BID)
Patients in this group will receive the same chemotherapy as Arm 1, combined with an escalated thoracic radiotherapy dose: 60 Gy delivered in 40 fractions of 1.5 Gy twice daily (BID). Dose may be reduced to 54 Gy if organs at risk exceed tolerance.
Experimental: Simultaneous Integrated Boost Radiotherapy Arm (45-54 Gy BID)
Patients in this group will receive the same chemotherapy as in other arms, with thoracic radiotherapy delivered as a simultaneous integrated boost (SIB): 45 Gy to the general target volume and 54 Gy to the high-risk clinical target volume (CTV) in 30 fractions BID.