Brain MetastasesPhase 3NCT03778541
HFSRT With Concurrent TMZ for Large BMs
A Phase 3 study testing Temozolomide and hypofractionated radiotherapy in people with Brain Metastases and Chemotherapy, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases, Chemotherapy, Radiotherapy
- What is being tested?
- Temozolomide and hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2018to 3 Dec 2022
- Phase
- Phase 3
- 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
- histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
- the number of BMs ≤ 3
- the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
- Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
- Age: 18-75 years old;
- Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.
Who cannot join
- patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
- unable or unwilling to comply with the study protocol;
- patient whose survival expectancy was less than 3 months;
- the large BM locates in brainstem;
- patient who anticipated in other clinical trials of brain metastases;
- the large lesions have been treated with SRT in other hospitals;
- pregnant patients or female patients whose HCG is positive.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianping Xiao, Dr, 86-13811026919, jpxiao8@163.com
About this study
Official title: Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Read the detailed description
A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.
- Conditions
- Brain Metastases, Chemotherapy, Radiotherapy
- Being tested
- Temozolomide, hypofractionated radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
hypofractionated radiotherapyRadiation
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
| Study group | Role | What they receive |
|---|---|---|
| CRT group | Experimental | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. Receives: Drug: Temozolomide; Radiation: hypofractionated radiotherapy |
| RT group | Active comparator | patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. Receives: Radiation: hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial progression free survival (IPFS) rate
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
Measured: up to 2 years
Secondary outcomes (4)
local control rate
the control rate of treated lesions
Measured: up to 2 years
Brain metastasis-specific survival (BMSS) rate
BMSS was defined as the internal from the beginning of RT to death caused by BM
Measured: up to 2 years
overall survival (OS) rate
OS was defined as the internal from the beginning of RT to death caused by any reason
Measured: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
the toxicities caused by RT and (or) Chemotherapy
Measured: acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start3 Dec 2018
- Primary completion3 Dec 2022 (estimated)
- Study completion3 Dec 2022 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
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, Dr, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778541
- Sponsor's protocol ID
- LBM-RCT
- Status last verified
- Jul 2019
- First submitted
- 9 Dec 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT03778541
- Acronym / sponsor ID
- LBM-RCT
- Conditions
- Brain Metastases, Chemotherapy, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 3 Dec 2022 (estimated)
- Study completion
- 3 Dec 2022 (estimated)
- First posted
- 19 Dec 2018 (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.
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Detailed description
A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
| Arm | Type | Receives |
|---|---|---|
| CRT group | Experimental | Drug: Temozolomide, Radiation: hypofractionated radiotherapypatients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide. |
| RT group | Active comparator | Radiation: hypofractionated radiotherapypatients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
- the number of BMs ≤ 3
- the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
- Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
- Age: 18-75 years old;
Key exclusion criteria (7 listed)
- patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
- unable or unwilling to comply with the study protocol;
- patient whose survival expectancy was less than 3 months;
- the large BM locates in brainstem;
- patient who anticipated in other clinical trials of brain metastases;
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 |
|---|---|---|
| Temozolomide75mg/m2/d concurrent with radiotherapy, taken for at least 20 days. | Drug | CRT group |
| hypofractionated radiotherapythe regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions. | Radiation | CRT group, RT group |
Primary outcome
intracranial progression free survival (IPFS) rate
Time frame: up to 2 years
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
4 secondary outcomes
local control rate
Time frame: up to 2 years
Brain metastasis-specific survival (BMSS) rate
Time frame: up to 2 years
overall survival (OS) rate
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
Time frame: acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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, Dr principal investigator
Cancer Institute and Hospital, 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 Phase 3 study testing Temozolomide and hypofractionated radiotherapy in people with Brain Metastases and Chemotherapy, 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?
The sponsor lists 6 inclusion and 7 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 23 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jianping Xiao, Dr (+8613811026919, jpxiao8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial progression free survival (IPFS) rate (time frame: up to 2 years). 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 23 Jul 2019.