Clinical trial NCT01780675: Hippocampus Avoidance PCI vs PCI
Official title: Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Lung Cancer
Keywords: Prophylactic Cranial Irradiation
Hippocampal Avoidance Prophylactic Cranial Irradiation
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2013-01-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: neurocognitive decline
timeFrame: 4 months
Secondary outcomes:
measure: safety
timeFrame: 2 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Centre
city: Tilburg
country: Netherlands
facility: Instituut Verbeeten
Study officials:
affiliation: The Netherlands Cancer Institute
name: Jose Belderbos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497.