A pilot phase 2 study evaluating dose de-escalation in whole brain radiation therapy with simultaneous integrated boost for patients with brain metastases

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

This trial is a pilot, Phase 2, sequential two-cohort study designed to test two de-escalated whole brain radiation therapy (WBRT) dose levels and assess their ability to maintain acceptable in-brain distant control.

Detailed description of study

The purpose of this study is to assess whole brain radiation therapy (known as WBRT) given with simultaneous higher dose radiation (known as SIB) targeted at individual brain tumors and the effects this treatment may have on the following areas: tumor control, memory, and specific thought processes.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer,Solid Tumor
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Pathological diagnosis of any solid tumor histology (from any site in the body)
Pathological or clinical (i.e., by imaging) diagnosis of brain metastatic tumor lesions
Not a candidate for or eligible for but refused Gamma Knife radiosurgery
Exclusion Criteria
Previous radiation to the brain, including WBRT or brain radiosurgery
Life expectancy 6 months (as estimated per ds-GPA)
Inability to comply with treatment per investigator discretion
Inability to complete neurocognitive assessments per investigator discretion
Of note, tumor lesion number is not an inclusion or exclusion criteria as we are using volume-based criteria instead.

Updated on 04 Aug 2024. Study ID: 1703715651 (IUSCC-0605)

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