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Hippocampus Avoidance PCI vs PCI (HA-PCI vs PCI)

This study is not yet open for participant recruitment.
Verified January 2013 by The Netherlands Cancer Institute
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01780675
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • neurocognitive decline [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: February 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: 5 times 4Gy (total 20Gy) or 10 times 2.5Gy (total 25Gy). Dose depending on limited or extensive disease.
 Radiation: Radiation Prophylactic Cranial Irradiation
Experimental: Hippocampal Avoidance PCI
Radiation. Hippocampal Avoidance PCI. 5 times 4Gy (total 20Gy) or 10 times 2.5Gy (total 25Gy). Dose depending on limited or extensive disease
 Radiation: Radiation Hippocampal Avoidance PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Small Cell Lung Cancer patients (limited disease or extensive without brain metastases) candidate for PCI after a partial or complete response to chemotherapy or chemoradiation − Sufficient proficiency in Dutch

Exclusion Criteria:

  • Prior radiotherapy to the brain
  • central nervous system 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780675

Contacts
Contact: Jose Belderbos, MD, PhD +31 20 512 2174 j.belderbos@nki.nl

Locations
Netherlands
the Netherlands Cancer Institute Not yet recruiting
Amsterdam, Netherlands, 1066CX
Principal Investigator: Jose Belderbos, MD, PhD            
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
Investigators
Principal Investigator: Jose Belderbos, MD, PhD The Netherlands Cancer Institute
  More Information

No publications provided

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01780675     History of Changes
Other Study ID Numbers: M12PHA, unknown
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013