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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario de Torrecardenas
Coordinator of this site? Confirm its status
AlmeríaSpainNot yet recruiting
Hospital Universitario de Cruces
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BarakaldoSpainNot yet recruiting
Instituto Catalán de Oncología
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GironaSpainNot yet recruiting
Hospital Dr. Negrín
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Las Palmas de Gran CanariaSpainNot yet recruiting
Hospital Gregorio Marañon
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MadridSpainNot yet recruiting
Hospital Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Virgen de Arrixaca
Coordinator of this site? Confirm its status
MurciaSpainNot yet recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainRecruiting
Hospital Marques de Valdecilla
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SantanderSpainNot yet recruiting
Complejo Hospitalario Universitario de Santiago
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Santiago de CompostelaSpainNot yet recruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
Genesis Care
Coordinator of this site? Confirm its status
SevilleSpainNot yet recruiting
Hospital La Fe
Coordinator of this site? Confirm its status
ValenciaSpainNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.