Brain MetastasisPhase 2NCT02832635
A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
A Phase 2 study testing TMZ, WBRT with avoidance of hippocampus and WBRT without avoidance of hippocampus in people with Brain Metastasis and Radiation Therapy Complication, run by Sun Yat-sen University at 10 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastasis, Radiation Therapy Complication
- What is being tested?
- TMZ, WBRT with avoidance of hippocampus and WBRT without avoidance of hippocampus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 10 sitesChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No previous brain surgery or brain radiotherapy
- Without dysfunction of heart, lung, liver, kidney and hematopoiesis
- The primary carcinoma is under control
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Yun-fei Xia, Professor, 86-13602805461, xiayf@sysucc.org.cn
Xiaohui Wang, MD, 86-18826260661, wangxh@sysucc.org.cn
Guangdong Three Nine Brain Hospital
Guangzhou, Guangdong, 510000
Lin-bo Cai, Prof., 86-13503030491
Linbo Cai, Prof.
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000
Guo-long Liu, Prof., 86-13802527172
Guo-long Liu, Prof.
Guangzhou People's Liberation Army Hospital 421
Guangzhou, Guangdong, 510000
Si-Lang Zhou, Prof., 86-13189099597
Si-Lang Zhou, Prof.
Panyu Central Hospital
Guangzhou, Guangdong, 510000
Xiao-long Cao, Prof., 86-18922238053
Xiao-long Cao, Prof.
The First Affiliated Hospital, Jinan University
Guangzhou, Guangdong, 510000
Yi-ou Wang, Prof., 86-13602751067
Yi-ou Wang, Prof.
The Affiliated Cancer Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510095
Xun-fan Shao, Prof., +86-13902770926, xunfanshao@yahoo.com.cn
Xun-fan Shao, Prof.
Guangdong Provincial Hospital Of Chinese Medicine
Guangzhou, Guangdong, 510120
Gong Li, Prof., +86-13802915171, leegong@21cn.com
Gong Li, Prof.
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510120
Dao-li Niu, Prof., +86-13711101855, daoliniu@163.com
Dao-li Niu, Prof.
The Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Zhibin Cheng, Professor, 86-13926946708
Zhibin Cheng, Professor
About this study
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
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.
Read the 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.
- Conditions
- Brain Metastasis, Radiation Therapy Complication
- Being tested
- TMZ, WBRT with avoidance of hippocampus, WBRT without avoidance of hippocampus
- Keywords
- brain metastasis, whole-brain radiotherapy, TMZ, avoidance of hippocampus
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMZDrug
Also called temozolomide
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
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 without avoidance of hippocampusRadiation
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
| Study group | Role | What they receive |
|---|---|---|
| WBRT | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied. Receives: 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. Receives: Radiation: WBRT with avoidance of hippocampus |
| WBRT with TMZ | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied. Receives: Drug: TMZ; Radiation: 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. Receives: Drug: TMZ; Radiation: WBRT with avoidance of hippocampus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of neurocognitive function between baseline and 4 months after radiotherapy
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
Measured: baseline; four months after radiotherapy
Secondary outcomes (2)
Effect on response rate
Response is evaluated on basis of RECIST
Measured: baseline; One, two, four, six, and twelve months after radiotherapy
The tolerance of radiotherapy with TMZ concurrent chemotherapy
Adverse effects are evaluated by CTCAE 4.0 criteria
Measured: baseline; once a week through during radiotherapy, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, Professor, Principal investigator, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832635
- Sponsor's protocol ID
- B2016-005-01
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02832635
- Acronym / sponsor ID
- B2016-005-01
- Conditions
- Brain Metastasis, Radiation Therapy Complication
- Keywords
- brain metastasis, whole-brain radiotherapy, TMZ, avoidance of hippocampus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WBRT | Experimental | Radiation: WBRT without avoidance of hippocampusPatients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied. |
| WBRT with avoidance of hippocampus | Experimental | Radiation: WBRT with avoidance of hippocampusPatients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied. |
| WBRT with TMZ | Experimental | Drug: TMZ, Radiation: WBRT without avoidance of hippocampusPatients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied. |
| WBRT with avoidance of hippocampus and TMZ | Experimental | Drug: TMZ, Radiation: WBRT with avoidance of hippocampusPatients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMZAlso: temozolomideTMZ 75mg/m2/d from the 1st day to the last day of radiotherapy | Drug | WBRT with TMZ, WBRT with avoidance of hippocampus and TMZ |
| WBRT with avoidance of hippocampusWhole 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. | Radiation | WBRT with avoidance of hippocampus, WBRT with avoidance of hippocampus and TMZ |
| WBRT without avoidance of hippocampusWhole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered. | Radiation | WBRT, WBRT with TMZ |
Primary outcome
Change of neurocognitive function between baseline and 4 months after radiotherapy
Time frame: baseline; four months after radiotherapy
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
2 secondary outcomes
Effect on response rate
Time frame: baseline; One, two, four, six, and twelve months after radiotherapy
The tolerance of radiotherapy with TMZ concurrent chemotherapy
Time frame: baseline; once a week through during radiotherapy, up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-fei Xia, Professor principal investigator
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMZ, WBRT with avoidance of hippocampus and WBRT without avoidance of hippocampus in people with Brain Metastasis and Radiation Therapy Complication, run by Sun Yat-sen University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-fei Xia, Professor (86-13602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of neurocognitive function between baseline and 4 months after radiotherapy (time frame: baseline; four months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.