2018-04-02
2023-03-31
2030-03-31
480
NCT03498326
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
INTERVENTIONAL
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.
We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.
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 |
|---|---|---|
2018-04-02 | N/A | 2018-05-27 |
2018-04-07 | N/A | 2018-05-30 |
2018-04-13 | N/A | 2018-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: gemcitabine one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection. | DRUG: Gemcitabine
DRUG: Gemcitabine
|
| EXPERIMENTAL: gemcitabine plus celecoxib the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period. | DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| disease free survival | the duration between the date of surgery and the date of disease relapse | Up to approximately 60 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| overall survival | the duration between the date of surgery and the date of patient death | Up to approximately 60 months |
| Carbohydrate antigen 19-9 | serum Carbohydrate antigen 19-9 level | Up to approximately 36 months |
| Quality of Life | assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score | Up to approximately 60 months |
| Common Toxicity Criteria for Adverse Effects | according to Common Toxicity Criteria for Adverse Effects version 4 | Up to approximately 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Tingbo Liang Phone Number: 13666676128 Email: [email protected] |
Study Contact Backup Name: Xueli Bai Phone Number: Email: [email protected] |
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:
This is where you will find people and organizations involved with this study.
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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