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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Biomédica de Salamanca

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

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators