Clinical trial · Interventional
Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)
Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)
NCT02397733CI-TRIAL-00053025completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients. In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hippocampal avoidance PCI | Radiation | — | UNRESOLVED |
| Prophylactic cranial irradiation (PCI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prophylactic cranial irradiation (PCI)
- description
- Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week
- interventionNames
- Radiation: Prophylactic cranial irradiation (PCI)
- type
- EXPERIMENTAL
- label
- Hippocampal avoidance PCI
- description
- Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week
- interventionNames
- Radiation: Hippocampal avoidance PCI
Primary outcomes (1)
- measure
- Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV * Performance status ≤ 1 * Negative MRI of the brain within one month before protocol entry * Patient must give written informed consent before registration Exclusion Criteria: * Prior radiotherapy to the brain * History of brain metastases * Pregnancy or lactation
References
Publications (4)
- DERIVEDZeng H, Schagen SB, Hendriks LEL, Sanchez-Benavides G, Jaspers JPM, Manero RM, Lievens Y, Murcia-Mejia M, Kuenen M, Rico-Oses M, Albers EAC, Samper P, Houben R, de Ruiter MB, Dieleman EMT, Lopez-Guerra JL, De Jaeger K, Counago F, Lambrecht M, Calvo-Crespo P, Belderbos JSA, De Ruysscher DKM, Rodriguez de Dios N. Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials. Lung Cancer. 2025 Jan;199:108036. doi: 10.1016/j.lungcan.2024.108036. Epub 2024 Nov 23. PMID 39615412
- DERIVEDIshibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497. PMID 34632876
- DERIVEDRodriguez de Dios N, Counago F, Murcia-Mejia M, Rico-Oses M, Calvo-Crespo P, Samper P, Vallejo C, Luna J, Trueba I, Sotoca A, Cigarral C, Farre N, Manero RM, Duran X, Gispert JD, Sanchez-Benavides G, Rognoni T, Torrente M, Capellades J, Jimenez M, Cabada T, Blanco M, Alonso A, Martinez-San Millan J, Escribano J, Gonzalez B, Lopez-Guerra JL. Randomized Phase III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small-Cell Lung Cancer (PREMER): A GICOR-GOECP-SEOR Study. J Clin Oncol. 2021 Oct 1;39(28):3118-3127. doi: 10.1200/JCO.21.00639. Epub 2021 Aug 11. PMID 34379442
- DERIVEDRodriguez de Dios N, Counago F, Lopez JL, Calvo P, Murcia M, Rico M, Vallejo C, Luna J, Trueba I, Cigarral C, Farre N, Manero RM, Duran X, Samper P. 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. Clin Lung Cancer. 2018 Sep;19(5):e693-e697. doi: 10.1016/j.cllc.2018.05.003. Epub 2018 May 10. PMID 29891263