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ClinicalTrials.gov ID

NCT02832635

Lead Sponsor

Sun Yat-sen UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

256Estimated

Last Update Posted

Jul 14, 2016Estimated

Start Date

Jul 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2017Estimated

Official Title

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

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.

• Brain Metastasis
• Radiation Therapy Complication

• TMZ
• WBRT with avoidance of hippocampus
• WBRT without avoidance of hippocampus

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Fifth Affiliated Hospital, Sun Yat-Sen UniversityOTHER

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