Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
Recruiting
Phase 3
Interventional Study
Small Cell Lung Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Instituto de Investigación Biomédica de Salamanca · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
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 radi…
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