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Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial

Phase 3
18 Years
Open (Enrolling)
Small Cell Lung Cancer, Lung Cancer

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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:


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:


Principal Investigator

Jose Belderbos, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Netherlands Cancer Institute


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




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