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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Fifth Affiliated Hospital, Sun Yat-Sen University
• Treatments: Temozolomide

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