Actively Recruiting
Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2026-03-31
300
Participants Needed
13
Research Sites
148 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Biomédica de Salamanca
Lead Sponsor
S
Spanish Lung Cancer Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- ECOG performance status 0-2
- No prior thoracic radiotherapy
- Signed informed consent
- Adequate blood counts: WBC 2 3.0 x10�9/L, neutrophils 2 1.5 x10�9/L, platelets 2 100 x10�9/L, hemoglobin 2 90 g/L
- Adequate liver and kidney function: total bilirubin 2 1.5 times upper limit normal, AST/ALT 2 1.5 times upper limit normal, creatinine normal or creatinine clearance 2 60 mL/min
- Lung function: FEV1 greater than 1 L or more than 30% predicted; DLCO more than 30% predicted
You will not qualify if you...
- Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)
- Malignant cells present in pleural or pericardial fluid
- Serious uncontrolled systemic disorders such as active infection or unstable cardiovascular disease
- Medical, psychological, or social conditions that could interfere with study compliance
- Active cancers other than SCLC, except localized prostate or breast cancer or basal cell carcinoma
- Refusal or inability to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
2
Hospital Universitario de Torrecardenas
Almería, Spain
Not Yet Recruiting
3
Hospital Universitario de Cruces
Barakaldo, Spain
Not Yet Recruiting
4
Instituto Catalán de Oncología
Girona, Spain
Not Yet Recruiting
5
Hospital Dr. Negrin
Las Palmas de Gran Canaria, Spain
Not Yet Recruiting
6
Hospital Gregorio Marañon
Madrid, Spain
Not Yet Recruiting
7
Hospital Ramon y Cajal
Madrid, Spain
Actively Recruiting
8
Hospital Universitario Virgen de Arrixaca
Murcia, Spain
Not Yet Recruiting
9
Hospital Marques de Valdecilla
Santander, Spain
Not Yet Recruiting
10
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Not Yet Recruiting
11
Genesis Care
Seville, Spain
Not Yet Recruiting
12
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
13
Hospital La Fe
Valencia, Spain
Not Yet Recruiting
Research Team
I
Iñigo San Miguel Arregui, MD PhD
CONTACT
C
Cristina Cigarral García, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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