Hippocampus Avoidance PCI vs PCI

Phase 3

Completed

• Conditions: Small Cell Lung Cancer; Lung Cancer
• Interventions: Radiation: Radiation Prophylactic Cranial Irradiation; Radiation: Radiation Hippocampal Avoidance PCI

• Registration Number: NCT01780675
• Lead Sponsor: The Netherlands Cancer Institute

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 available

Study Timeline

• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Study Start: 2013-04
• Primary Completion: 2019-04-01
• Status Verified: 2022-01
• Study Completion: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prophylactic Cranial Irradiation	Radiation Prophylactic Cranial Irradiation	Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)
Hippocampal Avoidance PCI	Radiation Hippocampal Avoidance PCI	Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).

Primary Outcome Measures

Name	Time	Method
neurocognitive decline	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 Outcome Measures

Name	Time	Method
safety	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

Trial Locations

Locations (9)

Instituut Verbeeten; 🇳🇱 Tilburg, Netherlands

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Erasmus MC Cancer Centre; 🇳🇱 Rotterdam, Netherlands

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands