NCT07015892RecruitingPhase 3
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 · Last updated 31 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 May 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Diseases
- Lung cancer
- NCT number
- NCT07015892
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 1 Mar 2026 to the primary completion date, 1 Sept 2028
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)
Other illness
- 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)
Other
- Refusal or inability to sign informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Torrecardenas Coordinator of this site? Confirm its status | Almería | Spain | Not yet recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Not yet recruiting |
| Instituto Catalán de Oncología Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital Dr. Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Not yet recruiting |
| Hospital Gregorio Marañon Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| Complejo Hospitalario Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Not yet recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Genesis Care Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Hospital La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.