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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

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 31, 2013
Last Update Posted Date August 4, 2021
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hippocampus Avoidance PCI vs PCI
Official Title  ICMJE Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Small Cell Lung Cancer
  • Lung Cancer
Intervention  ICMJE
  • Radiation: Radiation Prophylactic Cranial Irradiation
  • Radiation: Radiation Hippocampal Avoidance PCI
Study Arms  ICMJE
  • Active Comparator: Prophylactic Cranial Irradiation
    Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
    Intervention: Radiation: Radiation Prophylactic Cranial Irradiation
  • Experimental: Hippocampal Avoidance PCI
    Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).
    Intervention: Radiation: Radiation Hippocampal Avoidance PCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780675
Other Study ID Numbers  ICMJE M12PHA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Dutch Cancer Society
Investigators  ICMJE
Principal Investigator: Jose Belderbos, MD, PhD The Netherlands Cancer Institute
PRS Account The Netherlands Cancer Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP