NCT02832635|UnknownPhase 2DMC

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

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

Sun Yat-sen University ClinicalTrials.gov

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1 other identifier

B2016-005-01

Study Type

interventional

Target

256

Locations

1 country

Sites

Timeline

RegisteredJul 2016

StartedJul 2016

CompletionDec 2017

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

256

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach

1 country

10 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

June 14, 2016

Completed

17 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed

13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

July 14, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

June 14, 2016

Last Update Submit

July 11, 2016

Conditions

Brain Metastasis Radiation Therapy Complication

Keywords

brain metastasiswhole-brain radiotherapyTMZavoidance of hippocampus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Effect on response rate
baseline; One, two, four, six, and twelve months after radiotherapy
The tolerance of radiotherapy with TMZ concurrent chemotherapy
baseline; once a week through during radiotherapy, up to 3 weeks

Study Arms (4)

WBRT

EXPERIMENTAL

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

Radiation: WBRT without avoidance of hippocampus

WBRT with avoidance of hippocampus

EXPERIMENTAL

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

Radiation: WBRT with avoidance of hippocampus

WBRT with TMZ

EXPERIMENTAL

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

Drug: TMZRadiation: WBRT without avoidance of hippocampus

WBRT with avoidance of hippocampus and TMZ

EXPERIMENTAL

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

Drug: TMZRadiation: WBRT with avoidance of hippocampus

Interventions

TMZDRUG

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

Also known as: temozolomide

WBRT with TMZWBRT with avoidance of hippocampus and TMZ

WBRT with avoidance of hippocampusRADIATION

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 with avoidance of hippocampusWBRT with avoidance of hippocampus and TMZ

WBRT without avoidance of hippocampusRADIATION

Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.

WBRTWBRT with TMZ

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.