About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Thoracic Radiotherapy 45 Gy BID
- Thoracic Radiotherapy 60 Gy BID
- Thoracic Radiotherapy SIB 45-54 Gy BID
Treatment groups
Sponsors and collaborators
Instituto de Investigación Biomédica de Salamanca
Lead sponsor
Spanish Lung Cancer Group
Collaborator