Hippocampus Avoidance PCI vs PCI

Conditions

Lung Cancer, Small Cell Lung Cancer

Keywords

Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation

Brief summary

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.

Rob Colaes, Jeroen Blommaert, Maarten Lambrecht, Michiel B. de Ruiter, Pim Pullens et al. (10 authors)

Neuro-Oncology2024-12-231 citations

10.1093/neuonc/noae271

Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials.

Zeng H, Schagen SB, Hendriks LEL, Sánchez-Benavides G, Jaspers JPM, Manero RM, Lievens Y, Murcia-Mejía M, Kuenen M, Rico-Oses M, Albers EAC, Samper P, Houben R, de Ruiter MB, Dieleman EMT, López-Guerra JL, De Jaeger K, Couñago F, Lambrecht M, Calvo-Crespo P, Belderbos JSA, De Ruysscher DKM, Rodríguez de Dios N.

2024-11-233 citations

10.1016/j.lungcan.2024.108036

Association of Serum Biomarkers With Neurocognitive Decline After PCI in Small Cell Lung Cancer: An Exploratory Study of the Phase III NCT01780675 Trial.

Zeng H, Hendriks LEL, Belderbos J, Brandts L, Compter I, Dubois L, Holt MG, Houben R, Schagen S, Zhang X, Prezzemolo T, De Ruysscher D.

2024-08-221 citations

10.1016/j.cllc.2024.08.008

Hippocampal avoidance whole-brain radiotherapy with simultaneous integrated boost in lung cancer brain metastases and utility of the Hopkins verbal learning test for testing cognitive impairment in Chinese patients: a prospective phase II study

Zhuoran Li, Jianyang Wang, Lei Deng, Yirui Zhai, Tao Zhang et al. (15 authors)

BMC Cancer2024-07-267 citations

10.1186/s12885-024-12559-1

Quality assurance and safety of hippocampal avoidance prophylactic cranial irradiation in the multicenter randomized phase III trial (NCT01780675).

Candiff O, Belderbos J, Wolf AL, Damen E, van Haaren P, Crijns W, Hol S, Paelinck L, van Kesteren Z, Jaspers J, de Kerf G, van Elmpt W, Ubbels F, Schagen S, de Ruysscher D, de Ruiter M.

2023-05-192 citations

10.1016/j.jncc.2023.05.004

Self-Reported Cognitive Function and Quality of Life in Patients With SCLC in the Hippocampal Avoidance Prophylactic Cranial Irradiation Versus Prophylactic Cranial Irradiation Randomized Phase 3 Trial (NCT01780675).

Albers EAC, Zeng H, De Ruysscher DKM, Kuenen MA, Kessels R, Hendriks LEL, Belderbos JSA, Schagen SB.

2023-03-246 citations

10.1016/j.jtocrr.2023.100506

Prophylactic cranial irradiation (PCI) versus active surveillance in patients with limited-stage small cell lung cancer: a retrospective, multicentre study

Yu Chen, Yao Wang, Fei Ren, Zhaoqin Huang, Bingxu Tan et al. (10 authors)

Respiratory Research2022-10-0216 citations

10.1186/s12931-022-02196-2

Hippocampal avoidance prophylactic cranial irradiation (HA-PCI) for small cell lung cancer reduces hippocampal atrophy compared to conventional PCI

Michiel B. de Ruiter, P.F.C. Groot, Sabine Deprez, Pim Pullens, Stefan Sunaert et al. (8 authors)

Neuro-Oncology2022-05-3127 citations

10.1093/neuonc/noac148

Phase 3 Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampus Avoidance in SCLC (NCT01780675).

Belderbos JSA, De Ruysscher DKM, De Jaeger K, Koppe F, Lambrecht MLF, Lievens YN, Dieleman EMT, Jaspers JPM, Van Meerbeeck JP, Ubbels F, Kwint MH, Kuenen MA, Deprez S, De Ruiter MB, Boogerd W, Sikorska K, Van Tinteren H, Schagen SB.

2021-02-02106 citations

10.1016/j.jtho.2020.12.024

Neuro-cognitive (HVLT-R total recall) functioning in localized vs. metastatic small-cell lung cancer with or without hippocampus sparing PCI: Results from a phase III trial

Jan P. van Meerbeeck, Dirk De Ruysscher, J. Belderbos, Karin De Jaeger, F. Koppe et al. (17 authors)

Lung Cancer2019-09-286 citations

10.1183/13993003.congress-2019.oa5103

Interventions

RADIATIONRadiation Prophylactic Cranial Irradiation

RADIATIONRadiation Hippocampal Avoidance PCI

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
neurocognitive decline	4 months	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.

Secondary

Measure	Time frame	Description
safety	2 years	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

Countries

Belgium, Netherlands

Outcome results

None listed