Hippocampus Avoidance PCI vs PCI

Lung Cancer Clinical Trial

— HA-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780675
• Other study ID #: M12PHA
• Status: Completed
• Phase: Phase 3
• Start date: April 2013
• Est. completion date: January 2022

Study information

• Verified date: January 2022
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2022
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Radiation:
• Radiation Prophylactic Cranial Irradiation

• Radiation Hippocampal Avoidance PCI

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	The Netherlands Cancer Institute	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Erasmus MC Cancer Centre	Rotterdam
Netherlands	Instituut Verbeeten	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Dutch Cancer Society

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	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	2 years