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

Overview

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.

Full Title of Study: “Effectiveness and Safety of Whole-brain Radiotherapy With/Without TMZ Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases: a Multi-institutional, Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2017

Detailed Description

This is a phase II randomized clinical trial. It is reported that avoidance of hippocampus during whole-brain radiotherapy (WBRT) had benefits in preservation of memory for patients, and the use of concurrent TMZ in radiotherapy for patients with brain metastases benefited for treating outcome. The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy 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.

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.

Arms, Groups and Cohorts

  • Experimental: WBRT
    • Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
  • Experimental: WBRT with avoidance of hippocampus
    • Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
  • Experimental: WBRT with TMZ
    • Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
  • Experimental: WBRT with avoidance of hippocampus and TMZ
    • Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.

Clinical Trial Outcome Measures

Primary Measures

  • Change of neurocognitive function between baseline and 4 months after radiotherapy
    • Time Frame: baseline; four months after radiotherapy
    • Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)

Secondary Measures

  • Effect on response rate
    • Time Frame: baseline; One, two, four, six, and twelve months after radiotherapy
    • Response is evaluated on basis of RECIST
  • The tolerance of radiotherapy with TMZ concurrent chemotherapy
    • Time Frame: baseline; once a week through during radiotherapy, up to 3 weeks
    • Adverse effects are evaluated by CTCAE 4.0 criteria

Participating in This Clinical Trial

Inclusion Criteria

  • Primary lesions diagnosed by pathology or cytology – Brain metastases confirmed by brain MRI or CT(>3 brain metastases) – Brain metastases beyond 5mm of hippocampus – Male or female patients with age between 18 and 75 years old – Karnofsky Performance Scores ≥ 60 – Expected survival ≥ 6 months – No previous brain surgery or brain radiotherapy – Without dysfunction of heart, lung, liver, kidney and hematopoiesis – The primary carcinoma is under control Exclusion Criteria:

  • MMSE score <27 – Dysfunction of heart, lung, liver, kidney or hematopoiesis – Severe neurological, mental or endocrine diseases – History of alcohol or drug abuse within 3 months – Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test – Currently under treatment may effect patients' neurocognitive functions – Patients participated in clinical trials of other drugs within last 3 months – Other unsuitable reason

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Fifth Affiliated Hospital, Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yun-fei Xia, Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor – Sun Yat-sen University
  • Overall Official(s)
    • Yun-fei Xia, Professor, Principal Investigator, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
  • Overall Contact(s)
    • Yun-fei Xia, Professor, 86-13602805461, xiayf@sysucc.org.cn

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