Hippocampal Sparing Whole Brain Radiotherapy vs Conventional Whole Brain Radiotherapy in Patients With Brain Metastases
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
whole brain RT, hippocampal sparing, neurocognitive function
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hippocampal sparing whole brain radiotherapy Type: Radiation
Name: Conventional whole brain radiotherapy Type: Radiation
Overall Status
Not yet recruiting
Summary
The purpose of this study is to evaluate whether sparing the hippocampi during whole brain radiotherapy following neurosurgery or stereotactic radiosurgery in patients with brain metastases from a systemic tumour helps preserve brain function.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age ≥ 16 years

- Karnofsky Performance Status (KPS) ≥ 70

- Brain metastases from systemic malignancy which has been histologically confirmed (from the primary or any metastatic site)

- In total, at most 4 distinct brain metastases based on MRI imaging with contrast at any prior time-points

- Each of the brain metastases must either be in complete radiological remission on contrast MRI imaging, or have been treated by neurosurgery or by SRS in line with UK SRS commissioning guidelines within the following timeframes:

- If treated by neurosurgery only, the patient must be registered within 4 weeks of the date of neurosurgery (or of the first neurosurgery)

- If treated by SRS only, the patient must be registered within 4 weeks of treatment to each individual metastasis being completed (i.e. within 4 weeks of the last SRS fraction to each metastasis)

- If treated by both neurosurgery and SRS, then the patient must be registered within 6 weeks of the treatment to each individual metastasis being completed (i.e. within 6 weeks of the neurosurgery and within 6 weeks of the last SRS fraction to each metastasis)

- Ability to complete NCF test battery (including ability to speak English)

- Willing and able to give consent and to comply with treatment and follow up schedule

Exclusion Criteria:

- Metastases from small cell carcinoma, haematological malignancy, or central nervous system malignancy

- Leptomeningeal metastases

- Contraindication to MRI imaging with contrast

- Prior radiotherapy to the brain, apart from SRS for brain metastases completed within 6 weeks of trial registration

- Metastases currently or previously within 5 mm of either hippocampus

- Disease specific graded prognostic assessment (DS-GPA) score ≤ 1.0 for any of the histologies for which DS-GPA has been defined [Sperduto 2012]

- Women of childbearing potential who are known to be pregnant
Location
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Not yet recruiting
Contact: Gillian Whitfield - gillian.whitfield@christie.nhs.uk
Start Date
December 2014
Completion Date
December 2019
Sponsors
University College, London
Source
University College, London
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page