Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
Sponsor: Instituto de Investigación Biomédica de Salamanca
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
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-03-01
Completion Date
2028-12-31
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Thoracic Radiotherapy 45 Gy BID
45 Gy delivered in 30 fractions of 1.5 Gy twice daily over three weeks, with 95% of the planning target volume (PTV) receiving at least 95% of the prescribed dose.
Thoracic Radiotherapy 60 Gy BID
60 Gy delivered in 40 fractions of 1.5 Gy BID. A minimum dose of 54 Gy will be accepted if organ-at-risk tolerance is exceeded.
Thoracic Radiotherapy SIB 45-54 Gy BID
45 Gy in 30 fractions (1.5 Gy BID) to PTV and 54 Gy in 30 fractions (1.8 Gy BID) to high-risk CTV. Both delivered simultaneously using 3D conformal planning.
Locations (13)
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario de Torrecardenas
Almería, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Instituto Catalán de Oncología
Girona, Spain
Hospital Dr. Negrin
Las Palmas de Gran Canaria, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Ramon y Cajal
Madrid, 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 Virgen del Rocio
Seville, Spain
Hospital La Fe
Valencia, Spain