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

Brain Metastasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02832635
• Other study ID #: B2016-005-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 14, 2016
• Last updated: July 11, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Sun Yat-sen University
• Contact: Yun-fei Xia, Professor
• Phone: 86-13602805461
• Email: xiayf[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Radiation Therapy Complication

Intervention

Drug:
• TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy

Radiation:
• WBRT with avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.
• WBRT without avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Guangdong Provincial Hospital Of Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Three Nine Brain Hospital	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Guangzhou People's Liberation Army Hospital 421	Guangzhou	Guangdong
China	Panyu Central Hospital	Guangzhou	Guangdong
China	The Affiliated Cancer Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	The First Affiliated Hospital, Jinan University	Guangzhou	Guangdong
China	The Fifth Affiliated Hospital, Sun Yat-Sen University	Zhuhai	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of neurocognitive function between baseline and 4 months after radiotherapy	Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)	baseline; four months after radiotherapy	No
Secondary	Effect on response rate	Response is evaluated on basis of RECIST	baseline; One, two, four, six, and twelve months after radiotherapy	No
Secondary	The tolerance of radiotherapy with TMZ concurrent chemotherapy	Adverse effects are evaluated by CTCAE 4.0 criteria	baseline; once a week through during radiotherapy, up to 3 weeks	No