CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
intensity-modulated radiation therapyradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01227954
NCT01227954Phase 2Completed
CompareCT.gov

A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases

Radiation Therapy Oncology Group·interventional·Posted Oct 25, 2010·Updated Sep 27, 2017

In Brief

A Phase 2 clinical trial evaluating intensity-modulated radiation therapy for Cognitive/Functional Effects and 2 related conditions. Completed, enrolled 113 participants across 63 sites in 2 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2013
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.7 years ago

Interventions

intensity-modulated radiation therapyradiation

30 Gy in 10 fractions to the whole brain using intensity-modulated radiation therapy excluding the hippocampal avoidance area. Bilateral hippocampal contours manually generated on the fused planning MRI CT image set by the treating physician according to protocol-specified contouring instructions. Hippocampal avoidance regions generated by three-dimensionally expanding the hippocampal contours by 5 mm.