Non-small Cell Lung CancerPhase 2DP-EN-RTNCT01218594
Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
A Phase 2 study testing Endostatin in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC). 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?
- Endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age
- untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
- weight loss of less than 10% in the past 6 months
- performance status (PS) of 0 to 1
- forced vital capacity in 1 second (FEV1) higher than 0.8 L
- measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
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- absolute neutrophil count (ANC) of ≥ 1500/μL
- hemoglobin ≥ 10 mg/dL
- platelet ≥ 100,000/μL
- serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
- calculated creatinine clearance (CrCl) of ≥ 60 ml/min
- bilirubin 1.5×ULN
- AST and ALT less than 2.5×ULN
- alkaline phosphatase less than 5×ULN.
Who cannot join
- active infection
- history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- malnutrition (loss of ≥ 20% of the original body weight)
- sensor or motor neuropathy > grade I
- second primary malignancy, except for non-melanoma skin cancer
- psychiatric illness or social situation that would preclude study compliance
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- pregnant or lactating women
- preexisting bleeding diatheses or coagulopathy
- Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
Read the detailed description
OBJECTIVES:
Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
Secondary
- The progression-free survival (PFS)
- The overall survival(OS).
- The failed treatment modality.
- The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.
Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Endostatin
- Keywords
- Stage III, Unresectable, Non-small cell lung cancer
- 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.
EndostatinDrug
Also called Endostar
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Endostatin combine CCRT | Experimental | 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks Receives: Drug: Endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR)
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
Measured: 4 weeks after CCRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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.
- More trials run by Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University, Fujian Province Tumor Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, The Affiliated Tumor Hospital of Guangxi Medical University, Zhejiang Cancer Hospital, Guangzhou General Hospital of Guangzhou Military Command, The 458 Hospital of Chinese PLA
- Responsible party
- Principal investigator, Ming Chen, Sun Yat-sen University
- Investigators
- Ming Chen, Doctor, Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218594
- Sponsor's protocol ID
- DP-EN-RT
- Acronym
- DP-EN-RT
- Status last verified
- Aug 2012
- First submitted
- 1 Jun 2010
- Last updated
- 17 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.
PubMed 25497558
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01218594
- Acronym / sponsor ID
- DP-EN-RT / DP-EN-RT
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Stage III, Unresectable, Non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University, Fujian Province Tumor Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, The Affiliated Tumor Hospital of Guangxi Medical University, Zhejiang Cancer Hospital, Guangzhou General Hospital of Guangzhou Military Command, The 458 Hospital of Chinese PLA
- Study start
- May 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Posted 17 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
Detailed description
OBJECTIVES:
Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
Secondary
- The progression-free survival (PFS)
- The overall survival(OS).
- The failed treatment modality.
- The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.
Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostatin combine CCRT | Experimental | Drug: Endostatin7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years of age
Key exclusion criteria (9 listed)
- active infection
- history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- malnutrition (loss of ≥ 20% of the original body weight)
- sensor or motor neuropathy > grade I
- second primary malignancy, except for non-melanoma skin cancer
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 |
|---|---|---|
| EndostatinAlso: Endostar7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks | Drug | Endostatin combine CCRT |
Primary outcome
Response Rate (RR)
Time frame: 4 weeks after CCRT
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25497558Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.
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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.
Ming Chen, Doctor study chair
Sun Yat-Sen University Cancer Center
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 Endostatin in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University 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 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 17 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (RR) (time frame: 4 weeks after CCRT). 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 NCT01218594, 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 17 Oct 2012.