Clinical trial · Interventional
Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracic Radiotherapy 45 Gy BID | Radiation | — | UNRESOLVED |
| Thoracic Radiotherapy 60 Gy BID | Radiation | — | UNRESOLVED |
| Thoracic Radiotherapy SIB 45-54 Gy BID | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard Radiotherapy Arm (45 Gy BID)
- description
- Patients in this group will receive concurrent chemoradiotherapy consisting of cisplatin and etoposide with standard-dose thoracic radiotherapy: 45 Gy administered in 30 fractions of 1.5 Gy twice daily (BID).
- interventionNames
- Radiation: Thoracic Radiotherapy 45 Gy BID
- type
- EXPERIMENTAL
- label
- Escalated Dose Radiotherapy Arm (60 Gy BID)
- description
- Patients in this group will receive the same chemotherapy as Arm 1, combined with an escalated thoracic radiotherapy dose: 60 Gy delivered in 40 fractions of 1.5 Gy twice daily (BID). Dose may be reduced to 54 Gy if organs at risk exceed tolerance.
- interventionNames
- Radiation: Thoracic Radiotherapy 60 Gy BID
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available