Hippocampus Avoidance PCI vs PCI

The Netherlands Cancer Institute168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

168

Conditions

Small Cell Lung Cancer Lung Cancer

Interventions

Radiation Prophylactic Cranial IrradiationRADIATION

Radiation Hippocampal Avoidance PCIRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

The Netherlands Cancer Institute

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 4 months

Secondary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.