Non-small Cell Lung CancerPhase 4NCT01211002
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 4 study testing radiotherapy combined with EP and radiotherapy / EP combined with recombinant human endostatin in people with Non-small Cell Lung Cancer, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- radiotherapy combined with EP and radiotherapy / EP combined with recombinant human endostatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2012
- Phase
- Phase 4
- 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
- Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
- Patients with ages of 18~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss <10% during last 6 months;
- CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）
- No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value;
- Patients could understand the circumstances of this study and those who have signed the informed consent form;
Who cannot join
- Pregnant or lactating women; women of child-bearing age without contraception;
- Acute infection or other serious underlying diseases;
- Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
- Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
- Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
- Patients who are allergic to E. coli preparation;
- Patients who are unsuitable to participate in this trial determined by the researchers.
Trial locations and contacts
1 site in 1 country.
Zhenzhou Yang, M.D. contact
China1 site
Daping Hospital
Chongqin
zhenzhou yang, M.D., yangzhenzhou@sohu.com
zhenzhou yang, M.D.
About this study
Official title: The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- radiotherapy combined with EP, radiotherapy / EP combined with recombinant human endostatin
- Keywords
- Radiotherapy, rh-endostatin, chemotherapy, NSCLC
- 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.
radiotherapy combined with EPRadiation
Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
radiotherapy / EP combined with recombinant human endostatinDrug
Anti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy combined with EP | Active comparator | the dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses. Receives: Radiation: radiotherapy combined with EP |
| adiotherapy / EP /recombinant human endostatin | Experimental | recombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection. Receives: Drug: radiotherapy / EP combined with recombinant human endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: 3 years
Secondary outcomes (4)
quality of life
Measured: 2 years
objective response rate (ORR)
Measured: 1 years
disease control rate (DCR)
Measured: 1 year
progression-free survival (PFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- zhenzhou yang, M.D., Study chair, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211002
- Sponsor's protocol ID
- sim201002
- Status last verified
- Sep 2010
- First submitted
- 27 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )
- ClinicalTrials.gov ID
- NCT01211002
- Acronym / sponsor ID
- sim201002
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Radiotherapy, rh-endostatin, chemotherapy, NSCLC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Collaborators
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Sep 2010 (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.
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy combined with EP | Active comparator | Radiation: radiotherapy combined with EPthe dose of radiotherapy is 60-66 Gy / 30-33f.The combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses. |
| adiotherapy / EP /recombinant human endostatin | Experimental | Drug: radiotherapy / EP combined with recombinant human endostatinrecombinant human endostatin: The number of courses is 3 ~ 4 and each course last for 28 days.dose:15mg，d1-14, intravenous injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
- Patients with ages of 18~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss <10% during last 6 months;
- CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）
- No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value;
- Patients could understand the circumstances of this study and those who have signed the informed consent form;
Key exclusion criteria (7 listed)
- Pregnant or lactating women; women of child-bearing age without contraception;
- Acute infection or other serious underlying diseases;
- Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
- Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
- Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
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 |
|---|---|---|
| radiotherapy combined with EPTumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses. | Radiation | radiotherapy combined with EP |
| radiotherapy / EP combined with recombinant human endostatinAnti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection. | Drug | adiotherapy / EP /recombinant human endostatin |
Primary outcome
overall survival (OS)
Time frame: 3 years
4 secondary outcomes
quality of life
Time frame: 2 years
objective response rate (ORR)
Time frame: 1 years
disease control rate (DCR)
Time frame: 1 year
progression-free survival (PFS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
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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.
Zhenzhou Yang, M.D. contact
zhenzhou yang, M.D. study chair
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing radiotherapy combined with EP and radiotherapy / EP combined with recombinant human endostatin in people with Non-small Cell Lung Cancer, run by Simcere Pharmaceutical Co., Ltd 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 5 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 29 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhenzhou Yang, M.D. (yangzhenzhou@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 3 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 29 Sep 2010.