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Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer (GCRP)

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ClinicalTrials.gov Identifier: NCT03498326
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date  ICMJE April 2, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE April 2, 2018
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
disease free survival [ Time Frame: Up to approximately 60 months ]
the duration between the date of surgery and the date of disease relapse
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
  • overall survival [ Time Frame: Up to approximately 60 months ]
    the duration between the date of surgery and the date of patient death
  • Carbohydrate antigen 19-9 [ Time Frame: Up to approximately 36 months ]
    serum Carbohydrate antigen 19-9 level
  • Quality of Life [ Time Frame: Up to approximately 60 months ]
    assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score
  • Common Toxicity Criteria for Adverse Effects [ Time Frame: Up to approximately 12 months ]
    according to Common Toxicity Criteria for Adverse Effects version 4
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Official Title  ICMJE Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Chemotherapy Effect
Intervention  ICMJE
  • Drug: Gemcitabine
    One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.
  • Drug: Gemcitabine
    the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period.
    Other Name: celecoxib
Study Arms  ICMJE
  • Experimental: gemcitabine
    one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.
    Intervention: 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.
    Intervention: Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2018)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2030
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years old and above.
  2. Surgery for R0 resection.
  3. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.
  4. Eastern Cooperative Oncology Group score 0-2 points.
  5. Blood routine: The neutrophil count is at least 1.5*10^9/ml, and the platelet count is at least 100*10^9/ml.Hemoglobin is at least 80g/L.
  6. Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine ≤ 1.2 mg/dL.

Exclusion Criteria:

  1. Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).
  2. Surgery for pancreatic cancer fails to reach the R0 resection criteria.
  3. Pancreatic cancer received radiotherapy before surgery.
  4. Malignant brain metastases.
  5. There are other serious cancer history.
  6. Active infection, severe diarrhea.
  7. Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug History of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tingbo Liang 13666676128 liangtingbo@zju.edu.cn
Contact: Xueli Bai shirlybai@zju.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498326
Other Study ID Numbers  ICMJE SAHZhejiangU-GCRP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP