Hippocampus Avoidance PCI vs PCI (HA-PCI vs PCI)
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.
Small Cell Lung Cancer
Radiation: Radiation Prophylactic Cranial Irradiation
Radiation: Radiation Hippocampal Avoidance PCI
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial|
- neurocognitive decline [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]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.
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Prophylactic Cranial Irradiation
Radiation. Prophylactic Cranial Irradiation: 5 times 4Gy (total 20Gy) or 10 times 2.5Gy (total 25Gy). Dose depending on limited or extensive disease.
|Radiation: Radiation Prophylactic Cranial Irradiation|
Experimental: Hippocampal Avoidance PCI
Radiation. Hippocampal Avoidance PCI. 5 times 4Gy (total 20Gy) or 10 times 2.5Gy (total 25Gy). Dose depending on limited or extensive disease
|Radiation: Radiation Hippocampal Avoidance PCI|
|Contact: Jose Belderbos, MD, PhD||+31 20 512 firstname.lastname@example.org|
|The Netherlands Cancer Institute||Recruiting|
|Amsterdam, Netherlands, 1066CX|
|Contact: Jose Belderbos, MD, PhD +31 20 512 2135 email@example.com|
|Contact: Sanne Scahgen, PhD +31 20 512 2328 firstname.lastname@example.org|
|Principal Investigator: Jose Belderbos, MD, PhD|
|Principal Investigator:||Jose Belderbos, MD, PhD||The Netherlands Cancer Institute|