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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Active Comparator | Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy) |
|
| Hippocampal Avoidance PCI | Experimental | Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Prophylactic Cranial Irradiation | Radiation |
| ||
| Radiation Hippocampal Avoidance PCI |
| Measure | Description | Time Frame |
|---|---|---|
| neurocognitive decline | Each patient's total recall score recorded at 4 months will be compared to baseline and dichotomized into success (decline less or equal 5 points) or failure (decline more than 5 points). The difference between the groups, in terms of dichotomized decline will be tested by means of the Fisher's exact test. A p-value less than 0.049 will be considered significant. The primary analysis will be based on an intention-to-treat principle. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety | Brain metastases Time from randomization to the occurrence of brain metastases will be calculated and depicted in a cumulative incidence plot. Sensitivity analysis will be performed to assess the value of PCI vs HA-PCI treatment once considering patients dying without distant brain metastases to be censored and once using competing risk analysis considering distant metastases and death as separate events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Belderbos, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Antwerp | B-2650 | Belgium | |||
| Universitair Ziekenhuis Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39615412 | Derived | Zeng 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. | |
| 34632876 |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| Radiation |
|
| 2 years |
| Ghent |
| B-9000 |
| Belgium |
| Universitair Ziekenhuis Leuven | Leuven | B-3000 | Belgium |
| The Netherlands Cancer Institute | Amsterdam | 1066CX | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623EJ | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9700RB | Netherlands |
| Erasmus MC Cancer Centre | Rotterdam | 3075 EA | Netherlands |
| Instituut Verbeeten | Tilburg | 5042 SB | Netherlands |
| Derived |
| Ishibashi 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |