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Prophylactic Cranial Irradiation (PCI)

RADIATION8 trials

Sponsors

M.D. Anderson Cancer Center, Grupo de Investigación Clínica en Oncología Radioterapia, Peng Zhang, Merck Sharp & Dohme LLC, Shanghai Henlius Biotech

Conditions

Bladder CancerLimited Stage Small Cell Lung CancerLimited-Stage Small Cell Lung CancerLimited-stage Small Cell Lung Cancer (LS-SCLC)ProgressionRadiation ExposureRadiotherapy Side EffectSCLC, Limited Stage

Phase 2

Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium
Active, not recruitingNCT00756639
M.D. Anderson Cancer CenterBladder Cancer
Start: 2008-07-21End: 2027-12-31Updated: 2025-12-17
Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients
RecruitingNCT05443646
Cancer Institute and Hospital, Chinese Academy of Medical SciencesLimited Stage Small Cell Lung Cancer
Start: 2022-09-23End: 2025-06-30Target: 55Updated: 2024-05-07

Phase 3

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Active, not recruitingNCT04624204
Merck Sharp & Dohme LLCSmall Cell Lung Cancer
Start: 2020-12-08End: 2027-10-28Target: 672Updated: 2025-07-02
A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Active, not recruitingNCT05353257
Shanghai Henlius BiotechLimited-Stage Small Cell Lung Cancer
Start: 2022-05-17End: 2028-05-30Updated: 2026-01-13
Omitting CTV for Primary Tumor in LS-SCLC
RecruitingNCT07008716
Sun Yat-sen UniversityProgression, Radiation Exposure, Radiotherapy Side Effect +1
Start: 2025-06-03End: 2032-12-31Target: 852Updated: 2025-06-06

Unknown Phase

Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)
CompletedNCT02397733
Grupo de Investigación Clínica en Oncología RadioterapiaSmall Cell Lung Carcinoma
Start: 2014-09-30End: 2020-12-31Updated: 2021-08-02
Clinical Study of Combined Radical Operation With Postoperative Adjuvant Chemotherapy and Prophylactic Cranial Irradiation in pT1-2N0M0 Stage of Small Cell Lung Cancer
RecruitingNCT03514849
Peng ZhangSmall-cell Lung Cancer
Start: 2018-08-31End: 2026-03-31Target: 360Updated: 2018-08-07
Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy
RecruitingNCT06869239
Peking University Cancer Hospital & InstituteLimited-stage Small Cell Lung Cancer (LS-SCLC)
Start: 2025-02-25End: 2028-01-03Target: 65Updated: 2025-03-11

Related Papers

Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol
BMJ Open2025-05-012 citations
Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials.
2024-11-233 citations
216TiP A phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small cell lung cancer (ASTRUM-LC01)
ESMO Open2024-03-01
Phase 1 study of pembrolizumab plus chemotherapy in Japanese patients with extensive-stage small-cell lung cancer.
2024-02-01
Prophylactic cranial irradiation in small cell lung cancer: an update.
2022-11-245 citations
Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer.
2022-04-2911 citations
Phase 3 Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs. Concurrent Chemoradiation Therapy in Patients With Newly Diagnosed Limited-Stage Small-Cell Lung Cancer: KEYLYNK-013.
2021-11-01
KEYLYNK-013: A phase 3 study of pembrolizumab in combination with concurrent chemoradiation therapy followed by pembrolizumab with or without olaparib versus concurrent chemoradiation therapy in patients with newly diagnosed limited-stage SCLC.
Journal of Clinical Oncology2021-05-204 citations
Prophylactic cranial irradiation (PCI) significantly decreases risk of brain metastases in patients with bulky, higher stage small-cell urothelial cancer.
Journal of Clinical Oncology2019-03-012 citations
Treatment Design and Rationale for a Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for SCLC: PREMER Trial on Behalf of the Oncologic Group for the Study of Lung Cancer/Spanish Radiation Oncology Group-Radiation Oncology Clinical Research Group.
2018-05-1014 citations