Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 168
- Locations
- 9
- Primary Endpoint
- neurocognitive decline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Prophylactic Cranial Irradiation
Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
Intervention: Radiation Prophylactic Cranial Irradiation (Radiation)
Hippocampal Avoidance PCI
Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).
Intervention: Radiation Hippocampal Avoidance PCI (Radiation)
Outcomes
Primary Outcomes
neurocognitive decline
Time Frame: 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 Outcomes
- safety(2 years)