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

Phase 2

• Conditions: Radiation Therapy Complication; Brain Metastasis
• Interventions: Radiation: WBRT without avoidance of hippocampus; Radiation: WBRT with avoidance of hippocampus; Drug: TMZ

• Registration Number: NCT02832635
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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 Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-14
• Last Update Posted: 2016-07-14
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WBRT	WBRT without avoidance of hippocampus	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
WBRT with TMZ	WBRT without avoidance of hippocampus	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
WBRT with avoidance of hippocampus	WBRT with avoidance of hippocampus	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
WBRT with avoidance of hippocampus and TMZ	TMZ	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
WBRT with avoidance of hippocampus and TMZ	WBRT with avoidance of hippocampus	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
WBRT with TMZ	TMZ	Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Panyu Central Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital Of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou People's Liberation Army Hospital 421; 🇨🇳 Guangzhou, Guangdong, China

The Affiliated Cancer Hospital Of Guangzhou Medical Collage; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital Of Guangzhou Medical Collage; 🇨🇳 Guangzhou, Guangdong, China

The Fifth Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Zhuhai, Guangdong, China

Guangdong Three Nine Brain Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital, Jinan University; 🇨🇳 Guangzhou, Guangdong, China