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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

December 31, 2028

Conditions
Small Cell Lung Carcinoma
Interventions
RADIATION

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.

RADIATION

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.

RADIATION

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.

Trial Locations (13)

37007

Complejo Asistencial Universitario de Salamanca, Salamanca

Unknown

Hospital Universitario de Torrecardenas, Almería

Hospital Universitario de Cruces, Barakaldo

Instituto Catalán de Oncología, Girona

Hospital Dr. Negrin, Las Palmas de Gran Canaria

Hospital Gregorio Marañon, Madrid

Hospital Ramon y Cajal, Madrid

Hospital Universitario Virgen de Arrixaca, Murcia

Hospital Marques de Valdecilla, Santander

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

Genesis Care, Seville

Hospital Universitario Virgen del Rocio, Seville

Hospital La Fe, Valencia

All Listed Sponsors
collaborator

Spanish Lung Cancer Group

OTHER

lead

Instituto de Investigación Biomédica de Salamanca

OTHER

NCT07015892 - Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial | Biotech Hunter | Biotech Hunter