Non-small Cell Lung CancerPhase 3NCT00576914
Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
A Phase 3 study testing recombinant human endostatin in people with Non-small Cell Lung Cancer, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer. 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?
- recombinant human endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,108 participants
- Where
- 1 siteChina
- Study dates
- Jun 2007to Jun 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above.
- Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
- The time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks.
- No evidence of tumor relapse prior to adjuvant therapy.
- Age 18-70, ECOG performance status 0-1.
- Normal hematologic function.Renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, AST and ALT levels below 1.5 times of normal value.
- No history of chemotherapy or radiotherapy;
- The patient should have well compliance for chemotherapy and follow up.Informed consent should be obtained before treatment.
Who cannot join
- The histological or cytological documents do not match the inclusion criteria.
- Right side pneumonectomy or any kind of incompletely resected surgery.
- The recruitment time are beyond 8 weeks from surgery.
- Any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. The researchers can make a judge for the following conditions to tell whether they are fit for this research:Uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.Evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.Clinically significant active infection state due to bacteria, virus and fungi invasion. Patients with grade II arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade II high blood pressure or left ventricle ejection fraction (LVEF) less than 50 percent according to CTC 3.0 are not permitted to enrol the study.
- women with pregnant or lactation.
- Before enter the group,the patients had other malignant tumors except for non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.
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- With allergic constitution or possible allergic reflection to any known research drugs.
- Poor compliance.
- Not proper for the research according to the researchers' judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Lung Cancer Center of Cancer Hospital
Beijing, Beijing Municipality, 100021
Xinling Liu, Bachelor, 86-10-87788495, liuxinling1985@126.com
Fang Li, M.D., 86-13910145882, nc_lifang@yahoo.com.cn
About this study
Official title: Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer.
The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.
Read the detailed description
It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 5 years.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- recombinant human endostatin
- Keywords
- adjuvant therapy, non-small cell lung cancer, vinorelbine, cisplatin, recombinant human endostatin(endostar)
- 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.
recombinant human endostatinDrug
Also called endostar
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | vinorelbine plus cisplatin plus recombinant human endostatin Receives: Drug: recombinant human endostatin |
| B | No intervention | vinorelbine plus cisplatin Receives: Drug: recombinant human endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: five year
Secondary outcomes (1)
recurrence-free survival and the toxicity and safety of the regimens
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Beijing Chao Yang Hospital
- Investigators
- Jie He, M.D. & Ph.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576914
- Sponsor's protocol ID
- 2006 BAI02A02[1]-01
- Status last verified
- Mar 2009
- First submitted
- 18 Dec 2007
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.
PubMed 16945766
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)
- ClinicalTrials.gov ID
- NCT00576914
- Acronym / sponsor ID
- 2006 BAI02A02[1]-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- adjuvant therapy, non-small cell lung cancer, vinorelbine, cisplatin, recombinant human endostatin(endostar)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,108 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Beijing Chao Yang Hospital
- Study start
- Jun 2007
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 Dec 2007 (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 study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer.
The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.
Detailed description
It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: recombinant human endostatinvinorelbine plus cisplatin plus recombinant human endostatin |
| B | No intervention | Drug: recombinant human endostatinvinorelbine plus cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed non-small cell lung cancer, the pathology type includes squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of the 3 types mentioned above.
- Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
- The time from surgery to first dose of adjuvant chemotherapy are mandatory between 4-8 weeks.
- No evidence of tumor relapse prior to adjuvant therapy.
- Age 18-70, ECOG performance status 0-1.
Key exclusion criteria (9 listed)
- The histological or cytological documents do not match the inclusion criteria.
- Right side pneumonectomy or any kind of incompletely resected surgery.
- The recruitment time are beyond 8 weeks from surgery.
- Any concurrent acute or chronic systemic diseases or psychiatric diseases, which might both increase the risks of the research itself or the medical therapy and influence the research results analysis. The researchers can make a judge for the following conditions to tell whether they are fit for this research:Uncontrolled high blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or congestive heart failure with clinical symptoms within 12 weeks before randomization.Evidence of anemia from electrocardiographic manifestation or heart valve disease with confirmed clinical diagnosis.Clinically significant active infection state due to bacteria, virus and fungi invasion. Patients with grade II arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade II high blood pressure or left ventricle ejection fraction (LVEF) less than 50 percent according to CTC 3.0 are not permitted to enrol the study.
- women with pregnant or lactation.
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 |
|---|---|---|
| recombinant human endostatinAlso: endostarrecombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed | Drug | A, B |
Primary outcome
overall survival
Time frame: five year
1 secondary outcome
recurrence-free survival and the toxicity and safety of the regimens
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Background: PubMed 16945766Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.
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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.
Jie He, M.D. & Ph.D. study chair
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 recombinant human endostatin in people with Non-small Cell Lung Cancer, run by Chinese Academy of 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 8 inclusion and 9 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 9 Mar 2010. 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 Xinling Liu, Bachelor (86-10-87788495, liuxinling1985@126.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: five year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576914, which also lists 1 linked publication.
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 9 Mar 2010.