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Hippocampus Avoidance PCI vs PCI (HA-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01780675
Recruitment Status : Active, not recruiting
First Posted : January 31, 2013
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Study Start Date : April 2013
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 2021

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Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780675


Locations
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Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium, B-2650
Universitair Ziekenhuis Gent
Gent, Belgium, B-9000
Universitair Ziekenhuis Leuven
Leuven, Belgium, B-3000
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700RB
Erasmus MC Cancer Centre
Rotterdam, Netherlands, 3075 EA
Instituut Verbeeten
Tilburg, Netherlands, 5042 SB
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Investigators
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Principal Investigator: Jose Belderbos, MD, PhD The Netherlands Cancer Institute
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01780675    
Other Study ID Numbers: M12PHA
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Keywords provided by The Netherlands Cancer Institute:
Prophylactic Cranial Irradiation
Hippocampal Avoidance Prophylactic Cranial Irradiation
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms