Hippocampus Avoidance PCI vs PCI (HA-PCI)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
168 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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