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OpenTrials
Completed

NCT Number: NCT01780675

Hippocampus Avoidance PCI vs PCI

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Antwerpen, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation Prophylactic Cranial Irradiation

Radiation

Radiation Hippocampal Avoidance PCI

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

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

Acronym: HA-PCI

Important dates

Study start
2013
Primary completion
2019
Study completion
2022
First posted
Jan 31, 2013
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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