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

RecruitingPhase 3Ages 18 Years - anyAllInstituto de Investigación Biomédica de Salamanca
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * ECOG performance status 0-2 * No prior thoracic radiotherapy * Signed informed consent * Adequate hematologic function: WBC ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L * 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 Exclusion Criteria: * 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 * Active malignancy other than SCLC (except localized prostate/breast cancer or basal cell carcinoma) * Refusal or inability to sign informed consent
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What it tests

  • Thoracic Radiotherapy 45 Gy BID
  • Thoracic Radiotherapy 60 Gy BID
  • Thoracic Radiotherapy SIB 45-54 Gy BID
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Where

13 sites
Complejo Asistencial Universitario de 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

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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