Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy
Recruiting
Phase 3
Interventional Study
Limited Stage Small Cell Lung Cancer
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 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 534 (estimated)
- Sponsor
- Shandong Cancer Hospital and Institute · Other
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About This Trial
This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2);
2. Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST …
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