Hippocampus Avoidance PCI vs PCI
Conditions
Small Cell Lung Cancer - Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Radiation Prophylactic Cranial Irradiation Type: Radiation
Name: Radiation Hippocampal Avoidance PCI Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Iniversitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Status: Recruiting
Contact: Jan van Meerbeeck, MD, PhD - + 32 3 821 56 81 - jan.vanmeerbeeck@uza.be
Iniversitair Ziekenhuis Gent
Gent, Belgium
Status: Recruiting
Contact: Yolande Lievens, MD, PhD - +32 9 332 21 11 - y.lievens@uzgent.be
Universitair Ziekenhuis Leuven
Leuven, Belgium
Status: Recruiting
Contact: Dirk De Ruysscher, MD, PhD - +32 1 634 69 02 - dirk.deruysscher@uzleuven.be
Academisch Medisch Centrum
Amsterdam, Netherlands
Status: Not yet recruiting
Contact: Edith Dieleman, MD, PhD - +31 20 566 7990 - e.m.dieleman@amc.uva.nl
The Netherlands Cancer Institute
Amsterdam, Netherlands
Status: Recruiting
Contact: Jose Belderbos, MD, PhD - +31 20 512 2135 - j.belderbos@nki.nl
Catharina Ziekenhuis
Eindhoven, Netherlands
Status: Recruiting
Contact: Katrien de Jaeger, MD, PhD - +31 40 239 6400 - katrien.d.jaeger@catharinaziekenhuis.nl
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Status: Recruiting
Contact: Joachim Widder, MD - +31 50 361 0582 - j.widder@umcg.nl
Erasmus MC Cancer Centre
Rotterdam, Netherlands
Status: Not yet recruiting
Contact: John Praag, MD - +31 10 704 1507 - j.praag@erasmusmc.nl
Instituut Verbeeten
Tilburg, Netherlands
Status: Not yet recruiting
Contact: Frederike Koppe, MD - +31 13 594 7559 - koppe.f@bvi.nl
Start Date
April 2013
Completion Date
June 2021
Sponsors
The Netherlands Cancer Institute
Source
The Netherlands Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page