Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02832635

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sun Yat-sen University

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Not yet recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Brain Metastasis, Radiation Therapy Complication
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000

Site Contact

Yun-fei Xia, Professor

xiayf@sysucc.org.cn

86-13602805461

Guangdong Three Nine Brain Hospital, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangdong Three Nine Brain Hospital

Guangzhou, Guangdong, 510000

Site Contact

Lin-bo Cai, Prof.

86-13503030491

Guangzhou First People's Hospital, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000

Site Contact

Guo-long Liu, Prof.

86-13802527172

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangzhou People's Liberation Army Hospital 421

Guangzhou, Guangdong, 510000

Site Contact

Si-Lang Zhou, Prof.

86-13189099597

Panyu Central Hospital, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Panyu Central Hospital

Guangzhou, Guangdong, 510000

Site Contact

Xiao-long Cao, Prof.

86-18922238053

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

The First Affiliated Hospital, Jinan University

Guangzhou, Guangdong, 510000

Site Contact

Yi-ou Wang, Prof.

86-13602751067

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

The Affiliated Cancer Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510095

Site Contact

Xun-fan Shao, Prof.

xunfanshao@yahoo.com.cn

+86-13902770926

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangdong Provincial Hospital Of Chinese Medicine

Guangzhou, Guangdong, 510120

Site Contact

Gong Li, Prof.

leegong@21cn.com

+86-13802915171

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

The First Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510120

Site Contact

Dao-li Niu, Prof.

daoliniu@163.com

+86-13711101855

Zhuhai, Guangdong, China

Status

Not yet recruiting

Address

The Fifth Affiliated Hospital, Sun Yat-Sen University

Zhuhai, Guangdong, 519000

Site Contact

Zhibin Cheng, Professor

86-13926946708

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