Non Small Cell Lung CancerPhase 2NCT01347424
Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
A Phase 2 study testing Paclitaxel , carboplatin, endostatin and Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer and Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus paclitaxel and carboplatin regimen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Nasopharyngeal Cancer, Liver Metastasis
- What is being tested?
- Paclitaxel , carboplatin, endostatin and Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Oct 2014
- 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
- Histologic diagnosis of nasopharyngeal carcinoma or NSCLC
- With an evaluable secondary malignant neoplasm of Liver, diameter≥2cm
- Without transcatheter arterial chemoembolization (TACE) treatment
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Estimated life expectancy of at least 3 months
- Patient compliance and geographic proximity that allow adequate follow-up.
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- Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) >or= 1.5x10^9/L, platelets >or= 100x10^9/L, hemoglobin >or= 9g/dL. Hepatic: bilirubin <1.5 x ULN, alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x ULN (alkaline phosphatase, AST, ALT < 5 x ULN is acceptable if liver has tumor involvement). Renal: calculated creatinine clearance > 45 ml/min.
- Men or women of at least 18 years of age.
- Signed informed consent from patient.
Who cannot join
- Women who are pregnant or in lactation
- Systemic treatment for another cancer within the year prior to study entry
- Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study
Trial locations and contacts
1 site in 1 country.
About this study
Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus paclitaxel and carboplatin regimen.
- Being tested
- Paclitaxel , carboplatin, endostatin, Paclitaxel and Carboplatin
- Keywords
- NSCLC, NPC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel , carboplatin, endostatinDrug
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w
Paclitaxel and CarboplatinDrug
PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: Paclitaxel , carboplatin, endostatin |
| control group | Active comparator | Not described Receives: Drug: Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of blood flow perfusion in secondary malignant neoplasm of liver
Measured: 12months
Secondary outcomes (2)
Comparing the difference of OS(Overall Survival) and ORR(Objective Response Rate) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the two different arms.
Measured: 12 months
Number of Participants with Adverse Events in the two different arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2014 (estimated)
- Study completionOct 2014 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Principal investigator, Cancer Center of Sun Yat-Sen University (CCSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347424
- Sponsor's protocol ID
- XIANSHENG
- Status last verified
- Nov 2010
- First submitted
- 27 Apr 2011
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Endostatin Plus TC Regimen in Secondary Malignant Neoplasm of Liver Using Contrast Enhancement Ultrasonography
- ClinicalTrials.gov ID
- NCT01347424
- Acronym / sponsor ID
- XIANSHENG
- Keywords
- NSCLC, NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 4 May 2011 (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.
Contrast enhancement ultrasonography（CEUS）could be used to evaluate the blood flow perfusion liver cancer. In this clinical trial, CEUS was used to evaluated the changes of blood flow perfusion of Secondary Malignant Neoplasm of Liver after treated with endostatin plus paclitaxel and carboplatin regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Paclitaxel , carboplatin, endostatin |
| control group | Active comparator | Drug: Paclitaxel and Carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologic diagnosis of nasopharyngeal carcinoma or NSCLC
- With an evaluable secondary malignant neoplasm of Liver, diameter≥2cm
- Without transcatheter arterial chemoembolization (TACE) treatment
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Estimated life expectancy of at least 3 months
Key exclusion criteria (5 listed)
- Women who are pregnant or in lactation
- Systemic treatment for another cancer within the year prior to study entry
- Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study
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 |
|---|---|---|
| Paclitaxel , carboplatin, endostatinPTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w | Drug | Test group |
| Paclitaxel and CarboplatinPTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w | Drug | control group |
Primary outcome
The changes of blood flow perfusion in secondary malignant neoplasm of liver
Time frame: 12months
2 secondary outcomes
Comparing the difference of OS(Overall Survival) and ORR(Objective Response Rate) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the two different arms.
Time frame: 12 months
Number of Participants with Adverse Events in the two different arms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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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.
Li Zhang principal investigator
Cancer Center of Sun Yat-Sen University (CCSU)
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 Paclitaxel , carboplatin, endostatin and Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer and Nasopharyngeal 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 9 inclusion and 5 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 Dec 2013. 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?
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?
The changes of blood flow perfusion in secondary malignant neoplasm of liver (time frame: 12months). 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 9 Dec 2013.