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A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases

NCT02832635 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2016-07-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.

Conditions

  • Brain Metastasis
  • Radiation Therapy Complication

Interventions

DRUG

TMZ

TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy

RADIATION

WBRT with avoidance of hippocampus

Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.

RADIATION

WBRT without avoidance of hippocampus

Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, Professor · Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832635 on ClinicalTrials.gov