Clinical trial NCT02832635: A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Metastasis
Radiation Therapy Complication
Keywords: brain metastasis
whole-brain radiotherapy
TMZ
avoidance of hippocampus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fifth Affiliated Hospital, Sun Yat-Sen University
First posted: 2016-07-14
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Change of neurocognitive function between baseline and 4 months after radiotherapy
timeFrame: baseline; four months after radiotherapy
Secondary outcomes:
measure: Effect on response rate
timeFrame: baseline; One, two, four, six, and twelve months after radiotherapy
measure: The tolerance of radiotherapy with TMZ concurrent chemotherapy
timeFrame: baseline; once a week through during radiotherapy, up to 3 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Three Nine Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou People's Liberation Army Hospital 421
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Cancer Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital Of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
name: Yun-fei Xia, Professor
role: PRINCIPAL_INVESTIGATOR
References: