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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Radiation Therapy Complication; Brain Metastasis

Treatments: Drug: TMZ; Radiation: WBRT without avoidance of hippocampus; Radiation: WBRT with avoidance of hippocampus

Study type: Interventional

Funder types: Other

Identifiers

NCT02832635

B2016-005-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 4 patient groups

WBRT

Experimental group

Description:

Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.

Treatment:

Radiation: WBRT without avoidance of hippocampus

WBRT with avoidance of hippocampus

Experimental group

Description:

Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.

Treatment:

Radiation: WBRT with avoidance of hippocampus

WBRT with TMZ

Experimental group

Description:

Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.

Treatment:

Radiation: WBRT without avoidance of hippocampus

Drug: TMZ

WBRT with avoidance of hippocampus and TMZ

Experimental group

Description:

Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.

Treatment:

Drug: TMZ

Radiation: WBRT with avoidance of hippocampus