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

Sun Yat-sen University256 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

256

Conditions

Brain Metastasis Radiation Therapy Complication

Interventions

TMZDRUG

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

WBRT with avoidance of hippocampusRADIATION

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.

WBRT without avoidance of hippocampusRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Three Nine Brain Hospital

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change of neurocognitive function between baseline and 4 months after radiotherapy

Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)

Time frame: baseline; four months after radiotherapy

Secondary Outcomes

Effect on response rate

Response is evaluated on basis of RECIST

Time frame: baseline; One, two, four, six, and twelve months after radiotherapy

The tolerance of radiotherapy with TMZ concurrent chemotherapy

Adverse effects are evaluated by CTCAE 4.0 criteria

Time frame: baseline; once a week through during radiotherapy, up to 3 weeks

Central Contacts

Yun-fei Xia, Professor

CONTACT

86-13602805461 xiayf@sysucc.org.cn

Xiaohui Wang, MD

CONTACT

86-18826260661 wangxh@sysucc.org.cn

Data from ClinicalTrials.gov

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