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Clinical Trial Record

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Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

2013-04

2016-11-30

2017-03-31

14

Study Overview

Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor

N/A

  • Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
  • DRUG: temozolomide or dacarbazine-based chemotherapy, endostatin
  • TEPNET

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-04-29  

N/A  

2017-04-12  

2013-04-30  

N/A  

2017-04-13  

2013-05-03  

N/A  

2017-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: temozolomide or dacarbazine-based chemotherapy, endostatin

Endostatin 15mg/d，IV infusion, d1-d14 Temozolomide 150-200mg/m2/d，p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks.

DRUG: temozolomide or dacarbazine-based chemotherapy, endostatin

Primary Outcome MeasuresMeasure DescriptionTime Frame
overall response rateup to 12 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
progression free survivalFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
toxicitiesNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. 18 years of age and older 2. ECOG ≤2 3. Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor. 4. Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months 5. Disease progressed during or after last therapy 6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy 7. Disease progressed within the past 12 months。 8. Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated. 9. Adequate bone marrow, liver and renal function 10. Life expectancy 3 months or more 11. Patient informed consent。
    Exclusion Criteria:
    1. Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor. 2. 2 or more lines of prior chemotherapy。 3. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study 4. Uncontrolled infectious disease。 5. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin 6. Uncontrolled brain or leptomeningeal metastases 7. Patients with known hypersensitivity to temozolomide or endostatin。 8. Patient could not take tablets。

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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