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

July 11, 2016 updated by: Yun-fei Xia, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangzhou, Guangdong, China, 510000
        • Department of Radiation Oncology, Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Three Nine Brain Hospital
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou People's Liberation Army Hospital 421
      • Guangzhou, Guangdong, China, 510000
        • Panyu Central Hospital
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital, Jinan University
      • Guangzhou, Guangdong, China, 510095
        • The Affiliated Cancer Hospital Of Guangzhou Medical Collage
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital Of Guangzhou Medical Collage
      • Zhuhai, Guangdong, China, 519000
        • The Fifth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WBRT
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
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.
Experimental: WBRT with avoidance of hippocampus
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
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.
Experimental: WBRT with TMZ
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
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.
Drug: TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
Other Names:
  • temozolomide
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.
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.
Drug: TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
Other Names:
  • temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline; four months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on response rate
Time Frame: baseline; One, two, four, six, and twelve months after radiotherapy
Response is evaluated on basis of RECIST
baseline; One, two, four, six, and twelve months after radiotherapy
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
baseline; once a week through during radiotherapy, up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Yun-fei Xia, Professor, Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2016-005-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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