Brain MetastasesNCT04178330
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
A study testing tomotherapy in people with Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- tomotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2014to 13 Jun 2017
- Phase
- Interventional
- 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
Inclusion Criteria:Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3;KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 1.5x ULN, AST and ALT ≤ 1.5x ULN, BUN and Cr: within the normal range.
Exclusion Criteria: Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia). Unable or unwilling to comply with the study protocol.The expected survival time is less than 3 months. Patients who are anticipated in other clinical trials of brain metastases. Patients who has been treated with WBRT. Pregnant patients or female patients whose HCG is positive. Unsuitable to participate in study, that in the opinion of the treating physician.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.
Read the detailed description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).
- Conditions
- Brain Metastases
- Being tested
- tomotherapy
- Keywords
- multiple brain metastases, Tomotherapy, fractionated stereotactic radiotheray
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomotherapyRadiation
Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT). Receives: Radiation: tomotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate(DCR)
Using RTOG9508 criteria, tumor control is defined as CR+PR+SD
Measured: 2-3 month after radiation
Secondary outcomes (5)
Overall survival
the time from radiation to death
Measured: up to 3 years
progress free survival
the time from radiation to any progression
Measured: up to 1 year
local control rate
the time from radiation to the treated brain metastases recurrence
Measured: up to 1 year
intracranial progress free survival rate
the time from radiation to local recurrence and/or new brain metastases
Measured: up to 1 year
adverse event
acute and late toxicities
Measured: from the day of radiation, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Sep 2014
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Xiao, Chinese Academy of Medical Sciences
- Investigators
- Jianping Xiao, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178330
- Sponsor's protocol ID
- NCC2014 YZ-14-01
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial
- ClinicalTrials.gov ID
- NCT04178330
- Acronym / sponsor ID
- NCC2014 YZ-14-01
- Conditions
- Brain Metastases
- Keywords
- multiple brain metastases, Tomotherapy, fractionated stereotactic radiotheray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.
Detailed description
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Radiation: tomotherapypatients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| tomotherapyWhole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles. | Radiation | Group A |
Primary outcome
Disease control rate(DCR)
Time frame: 2-3 month after radiation
Using RTOG9508 criteria, tumor control is defined as CR+PR+SD
5 secondary outcomes
Overall survival
Time frame: up to 3 years
progress free survival
Time frame: up to 1 year
local control rate
Time frame: up to 1 year
intracranial progress free survival rate
Time frame: up to 1 year
adverse event
Time frame: from the day of radiation, up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Jianping Xiao principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomotherapy in people with Brain Metastases, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate(DCR) (time frame: 2-3 month after radiation). 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 26 Nov 2019.