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

Primary Purpose

Pancreatic Cancer, Chemotherapy Effect

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
Gemcitabine
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, gemcitabine, celecoxib, R0 resection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

gemcitabine

gemcitabine plus celecoxib

Arm Description

one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.

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.

Outcomes

Primary Outcome Measures

disease free survival
the duration between the date of surgery and the date of disease relapse

Secondary Outcome Measures

overall survival
the duration between the date of surgery and the date of patient death
Carbohydrate antigen 19-9
serum Carbohydrate antigen 19-9 level
Quality of Life
assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score
Common Toxicity Criteria for Adverse Effects
according to Common Toxicity Criteria for Adverse Effects version 4

Full Information

First Posted
April 2, 2018
Last Updated
May 27, 2018
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03498326
Brief Title
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Acronym
GCRP
Official Title
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Chemotherapy Effect
Keywords
pancreatic cancer, gemcitabine, celecoxib, R0 resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine
Arm Type
Experimental
Arm Description
one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.
Arm Title
gemcitabine plus celecoxib
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
celecoxib
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease free survival
Description
the duration between the date of surgery and the date of disease relapse
Time Frame
Up to approximately 60 months
Secondary Outcome Measure Information:
Title
overall survival
Description
the duration between the date of surgery and the date of patient death
Time Frame
Up to approximately 60 months
Title
Carbohydrate antigen 19-9
Description
serum Carbohydrate antigen 19-9 level
Time Frame
Up to approximately 36 months
Title
Quality of Life
Description
assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score
Time Frame
Up to approximately 60 months
Title
Common Toxicity Criteria for Adverse Effects
Description
according to Common Toxicity Criteria for Adverse Effects version 4
Time Frame
Up to approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old and above. Surgery for R0 resection. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies. Eastern Cooperative Oncology Group score 0-2 points. 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. 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: Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma). Surgery for pancreatic cancer fails to reach the R0 resection criteria. Pancreatic cancer received radiotherapy before surgery. Malignant brain metastases. There are other serious cancer history. Active infection, severe diarrhea. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingbo Liang
Phone
13666676128
Email
liangtingbo@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xueli Bai
Email
shirlybai@zju.edu.cn
Facility Information:
Facility Name
the second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Chen, MD,PhD
Phone
+8613857168284
Email
chen_qi@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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