Non-small-cell Lung CancerPhase 2TRACTSNCT01763385
Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases
A Phase 2 study testing Erlotinib, concurrent brain radiotherapy and secondary brain radiotherapy in people with Non-small-cell Lung Cancer and Brain Metastases, run by Wu Jieping Medical Foundation at 1 site in China.
Trial summary
This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-small-cell Lung Cancer, Brain Metastases
- What is being tested?
- Erlotinib, concurrent brain radiotherapy and secondary brain radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to May 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years old;
- Tissue or cell pathological diagnosis of NSCLC;
- Brain CT or MR validated BM;
- Non-increased-intracranial-pressure symptomatic BM;
- Haven't received TKI target treatment;
- Haven't received brain radiotherapy;
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- Patients in initial treatment should be detected EGFR mutation;
- Expected survival more than 6 months;
- KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
- Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
- Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L，no requirement for Hb;
- Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
- Female patients in childbearing age: HCG (-);
- Patients signed an inform Consent.
Who cannot join
- Those with Erlotinib drug allergies;
- Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
- Those without guardians or families;
- Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
- Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
- Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Huanjun Yang, Master, +86-21-64175590 ext. 6723, yanghj_1@hotmail.com
About this study
Official title: Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases: A Prospective Multicenter Trial(TRACTS)
This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.
- Conditions
- Non-small-cell Lung Cancer, Brain Metastases
- Being tested
- Erlotinib, concurrent brain radiotherapy, secondary brain radiotherapy
- Keywords
- Erlotinib, brain radiotherapy, NSCLC, brain metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
concurrent brain radiotherapyRadiation
secondary brain radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib & secondary brain radiotherapy | Experimental | Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Receives: Drug: Erlotinib; Radiation: secondary brain radiotherapy |
| Erlotinib & concurrent brain radiotherapy | Other | Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons Receives: Drug: Erlotinib; Radiation: concurrent brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3.5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (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.
- 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Jieping Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Changhai Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Longhua Hospital, RenJi Hospital, Shanghai Armed Police Hospital, Shanghai Chest Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
- Responsible party
- Principal investigator, Yang Huan Jun, Fudan University
- Investigators
- Huanjun Yang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763385
- Sponsor's protocol ID
- 2012-75-634
- Acronym
- TRACTS
- Status last verified
- Dec 2014
- First submitted
- 4 Jan 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases: A Prospective Multicenter Trial(TRACTS)
- ClinicalTrials.gov ID
- NCT01763385
- Acronym / sponsor ID
- TRACTS / 2012-75-634
- Conditions
- Non-small-cell Lung Cancer, Brain Metastases
- Keywords
- Erlotinib, brain radiotherapy, NSCLC, brain metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Wu Jieping Medical FoundationUniversity, hospital or other
- Collaborators
- Fudan University, Changhai Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Longhua Hospital, RenJi Hospital, Shanghai Armed Police Hospital, Shanghai Chest Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
- Study start
- Nov 2012
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 Jan 2013 (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.
This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib & secondary brain radiotherapy | Experimental | Drug: Erlotinib, Radiation: secondary brain radiotherapyErlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. |
| Erlotinib & concurrent brain radiotherapy | Other | Drug: Erlotinib, Radiation: concurrent brain radiotherapyErlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Over the age of 18 years old;
- Tissue or cell pathological diagnosis of NSCLC;
- Brain CT or MR validated BM;
- Non-increased-intracranial-pressure symptomatic BM;
- Haven't received TKI target treatment;
Key exclusion criteria (7 listed)
- Those with Erlotinib drug allergies;
- Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
- Those without guardians or families;
- Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
- Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
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 |
|---|---|---|
| Erlotinib | Drug | Erlotinib & concurrent brain radiotherapy, Erlotinib & secondary brain radiotherapy |
| concurrent brain radiotherapy | Radiation | Erlotinib & concurrent brain radiotherapy |
| secondary brain radiotherapy | Radiation | Erlotinib & secondary brain radiotherapy |
Primary outcome
overall survival
Time frame: 3.5year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Huanjun Yang principal investigator
Fudan University
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 Erlotinib, concurrent brain radiotherapy and secondary brain radiotherapy in people with Non-small-cell Lung Cancer and Brain Metastases, run by Wu Jieping Medical Foundation 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 14 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 Dec 2014. 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 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 Huanjun Yang, Master (+86-21-64175590 ext. 6723, yanghj_1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3.5year). 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 Dec 2014.