Non-small Cell Lung CancerPhase 2NCT03614065
Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
A Phase 2 study testing endostar and radiotherapy in people with Non-small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- endostar and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2017to Nov 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NSCLC Brain metastasis
Who cannot join
- KPS<60
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital
Wuhan, Hubei, 430000
dong xiaorong, Dr
About this study
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC
Read the detailed description
The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- endostar, Placebos, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endostarDrug
Also called An antiangiogenic drug
endostatin
PlacebosDrug
Also called negative control
saline solution
radiotherapyRadiation
radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| arm a | Placebo comparator | This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study Receives: Drug: Placebos; Radiation: radiotherapy |
| arm b | Experimental | This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine Receives: Drug: endostar; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
the time from the start of treatment to the progression of the brain metastases, in months
Measured: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months
Secondary outcomes (1)
Overall survival （OS）
the total survival time of the patient from the start of treatment
Measured: From date of randomization until the date of death, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start21 Feb 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- dong xiaorong, Dr, Study director, china goverment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614065
- Sponsor's protocol ID
- endobrain
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
- ClinicalTrials.gov ID
- NCT03614065
- Acronym / sponsor ID
- endobrain
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 3 Aug 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.
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC
Detailed description
The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm a | Placebo comparator | Drug: Placebos, Radiation: radiotherapyThis group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study |
| arm b | Experimental | Drug: endostar, Radiation: radiotherapyThis group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NSCLC Brain metastasis
Key exclusion criteria (1 listed)
- KPS<60
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 |
|---|---|---|
| endostarAlso: An antiangiogenic drugendostatin | Drug | arm b |
| PlacebosAlso: negative controlsaline solution | Drug | arm a |
| radiotherapyradiotherapy | Radiation | arm a, arm b |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months
the time from the start of treatment to the progression of the brain metastases, in months
1 secondary outcome
Overall survival （OS）
Time frame: From date of randomization until the date of death, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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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.
dong xiaorong, Dr study director
china goverment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing endostar and radiotherapy in people with Non-small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 1 inclusion and 1 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 3 Aug 2018. 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. Some participants in this study may receive a placebo. 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 dong xiaorong, Dr (15071116896, zrg27@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months). 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 3 Aug 2018.