Hippocampus Avoidance PCI vs PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Small Cell Lung Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prophylactic Cranial Irradiation

Radiation. Prophylactic Cranial Irradiation: 10 times 2.5 Gy (total 25 Gy)

Group Type ACTIVE_COMPARATOR

Radiation Prophylactic Cranial Irradiation

Intervention Type RADIATION

Hippocampal Avoidance PCI

Radiation. Hippocampal Avoidance PCI. 10 times 2.5 Gy (total 25 Gy).

Group Type EXPERIMENTAL

Radiation Hippocampal Avoidance PCI

Intervention Type RADIATION

Interventions

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Radiation Prophylactic Cranial Irradiation

Intervention Type RADIATION

Radiation Hippocampal Avoidance PCI

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No