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Hippocampus Avoidance PCI vs PCI (HA-PCI)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by The Netherlands Cancer Institute
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute Identifier:
First received: January 29, 2013
Last updated: December 7, 2016
Last verified: December 2016

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.

Condition Intervention Phase
Small Cell Lung Cancer Lung Cancer Radiation: Radiation Prophylactic Cranial Irradiation Radiation: Radiation Hippocampal Avoidance PCI Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial

Resource links provided by NLM:

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • neurocognitive decline [ Time Frame: 4 months ]
    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.

Secondary Outcome Measures:
  • safety [ Time Frame: 2 years ]
    Brain metastases Time from randomization to the occurrence of brain metastases will be calculated and depicted in a cumulative incidence plot. Sensitivity analysis will be performed to assess the value of PCI vs HA-PCI treatment once considering patients dying without distant brain metastases to be censored and once using competing risk analysis considering distant metastases and death as separate events

Estimated Enrollment: 168
Study Start Date: April 2013
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prophylactic Cranial Irradiation
Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
Radiation: Radiation Prophylactic Cranial Irradiation
Experimental: Hippocampal Avoidance PCI
Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).
Radiation: Radiation Hippocampal Avoidance PCI


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01780675

Contact: Jose Belderbos, MD, PhD +31 20 512 2174
Contact: Sanne Schagen, PhD + 31 20 512 2328

Iniversitair Ziekenhuis Antwerpen Recruiting
Antwerpen, Belgium, B-2650
Contact: Jan van Meerbeeck, MD, PhD    + 32 3 821 56 81   
Iniversitair Ziekenhuis Gent Recruiting
Gent, Belgium, B-9000
Contact: Yolande Lievens, MD, PhD    +32 9 332 21 11   
Universitair Ziekenhuis Leuven Recruiting
Leuven, Belgium, B-3000
Contact: Stephanie Peeters, MD, PhD    +32 1 634 69 02   
Contact: Sabine Deprez, MD, PhD    +32 1 634 90 70   
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Jose Belderbos, MD, PhD    +31 20 512 2135   
Contact: Sanne Schagen, PhD    +31 20 512 2328   
Principal Investigator: Jose Belderbos, MD, PhD         
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Edith Dieleman, MD, PhD    +31 20 566 7990   
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Katrien de Jaeger, MD, PhD    +31 40 239 6400   
Principal Investigator: Katrien de Jaeger, MD, PhD         
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: Joachim Widder, MD    +31 50 361 0582   
Erasmus MC Cancer Centre Recruiting
Rotterdam, Netherlands, 3075 EA
Contact: John Praag, MD    +31 10 704 1507   
Contact: Marjan vd Pol, MD, PhD    + 31 10 704 1507   
Instituut Verbeeten Recruiting
Tilburg, Netherlands, 5042 SB
Contact: Friderieke Koppe, MD    +31 13 594 7559   
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Principal Investigator: Jose Belderbos, MD, PhD The Netherlands Cancer Institute
  More Information

Responsible Party: The Netherlands Cancer Institute Identifier: NCT01780675     History of Changes
Other Study ID Numbers: M12PHA
Study First Received: January 29, 2013
Last Updated: December 7, 2016

Keywords provided by The Netherlands Cancer Institute:
Prophylactic Cranial Irradiation
Hippocampal Avoidance Prophylactic Cranial Irradiation

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on June 23, 2017