Clinical trial · Interventional
Hippocampus Avoidance PCI vs PCI
Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
- 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)
Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet. This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Hippocampal Avoidance PCI | Radiation | — | UNRESOLVED |
| Radiation Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prophylactic Cranial Irradiation
- description
- Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
- interventionNames
- Radiation: Radiation Prophylactic Cranial Irradiation
- type
- EXPERIMENTAL
- label
- Hippocampal Avoidance PCI
- description
- Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).
- interventionNames
- Radiation: Radiation Hippocampal Avoidance PCI
Primary outcomes (1)
- measure
- neurocognitive decline
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Small Cell Lung Cancer patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV * Sufficient proficiency in Dutch Exclusion Criteria: * Prior radiotherapy to the brain * Clinical evidence for brain metastases or primary brain tumors- Evidence of progressive extracranial metastatic disease * Previous malignancy \< 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix * Any systemic anticancer treatment during PCI or within 3 weeks before start PCI * Pregnancy or lactation
References
Publications (2)
- 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