Trial Information
Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Inclusion Criteria:
- Small Cell Lung Cancer patients (limited disease or extensive without brain
metastases) candidate for PCI after a partial or complete response to chemotherapy or
chemoradiation − Sufficient proficiency in Dutch
Exclusion Criteria:
- Prior radiotherapy to the brain
- central nervous system 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
neurocognitive decline
Outcome Description:
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.
Outcome Time Frame:
4 months
Safety Issue:
Yes
Principal Investigator
Jose Belderbos, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Netherlands Cancer Institute
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
M12PHA
NCT ID:
NCT01780675
Start Date:
April 2013
Completion Date:
June 2021
Related Keywords:
- Small Cell Lung Cancer
- Lung Cancer
- Prophylactic Cranial Irradiation
- Hippocampal Avoidance Prophylactic Cranial Irradiation
- Lung Neoplasms
- Small Cell Lung Carcinoma