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Hippocampus Avoidance PCI vs PCI (HA-PCI)

Primary Purpose

Small Cell Lung Cancer, Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radiation Prophylactic Cranial Irradiation
Radiation Hippocampal Avoidance PCI
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Universitair Ziekenhuis Leuven
  • The Netherlands Cancer Institute
  • Academisch Medisch Centrum
  • Catharina Ziekenhuis
  • Universitair Medisch Centrum Groningen
  • Erasmus MC Cancer Centre
  • Instituut Verbeeten

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prophylactic Cranial Irradiation

Hippocampal Avoidance PCI

Arm Description

Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)

Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).

Outcomes

Primary Outcome Measures

neurocognitive decline
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
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

Full Information

First Posted
January 29, 2013
Last Updated
January 20, 2022
Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT01780675
Brief Title
Hippocampus Avoidance PCI vs PCI
Acronym
HA-PCI
Official Title
Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
January 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Lung Cancer
Keywords
Prophylactic Cranial Irradiation, Hippocampal Avoidance Prophylactic Cranial Irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic Cranial Irradiation
Arm Type
Active Comparator
Arm Description
Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
Arm Title
Hippocampal Avoidance PCI
Arm Type
Experimental
Arm Description
Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).
Intervention Type
Radiation
Intervention Name(s)
Radiation Prophylactic Cranial Irradiation
Intervention Type
Radiation
Intervention Name(s)
Radiation Hippocampal Avoidance PCI
Primary Outcome Measure Information:
Title
neurocognitive decline
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
safety
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Belderbos, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
Erasmus MC Cancer Centre
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Instituut Verbeeten
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34632876
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.
Results Reference
derived

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Hippocampus Avoidance PCI vs PCI

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