Hippocampus Avoidance PCI vs PCI (HA-PCI)

January 20, 2022 updated by: The Netherlands Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, B-3000
        • Universitair Ziekenhuis Leuven
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1066CX
        • the Netherlands Cancer Institute
      • Eindhoven, Netherlands, 5623EJ
        • Catharina Ziekenhuis
      • Groningen, Netherlands, 9700RB
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus MC Cancer Centre
      • Tilburg, Netherlands, 5042 SB
        • Instituut Verbeeten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Jose Belderbos, MD, PhD, the Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (ESTIMATE)

January 31, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12PHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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