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GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03869294
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Weijia Fang, MD, Zhejiang University

Tracking Information
First Submitted Date March 8, 2019
First Posted Date March 11, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date January 1, 2014
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2019)
  • Progression-free survival [ Time Frame: 2014-01-01 to 2017-12-31 ]
    the time from the beginning of chemotherapy to the date of disease progression or death from any cause.
  • Overall survival [ Time Frame: 2014-01-01 to 2017-12-31 ]
    the time from the beginning of chemotherapy to the date of death from any cause.
Original Primary Outcome Measures
 (submitted: March 8, 2019)
  • PFS [ Time Frame: 2014-01-01 to 2017-12-31 ]
    progression-free survival
  • OS [ Time Frame: 2014-01-01 to 2017-12-31 ]
    overall survival
Change History Complete list of historical versions of study NCT03869294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 13, 2019)
  • Objective response rate [ Time Frame: 2014-01-01 to 2017-12-31 ]
    the percentage of patients with CR or PR
  • adverse events [ Time Frame: 2014-01-01 to 2017-12-31 ]
Original Secondary Outcome Measures
 (submitted: March 8, 2019)
  • ORR [ Time Frame: 2014-01-01 to 2017-12-31 ]
    Objective Response
  • adverse events [ Time Frame: 2014-01-01 to 2017-12-31 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients
Official Title Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer
Brief Summary Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All advanced pancreatic cancer patients are diagnosed by histology to have pancreatic adenocarcinoma after a biopsy and received first-line GS chemotherapy at the Cancer Biotherapy Center of the First Affiliated Hospital.
Condition
  • Pancreatic Cancer
  • Chemotherapy Effect
  • Chemotherapeutic Toxicity
Intervention Drug: GS
Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer
Study Groups/Cohorts LAPC or MPC patients with GS first-line chemotherapy
Intervention: Drug: GS
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 Completed
Actual Enrollment
 (submitted: March 8, 2019)
96
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function

Exclusion Criteria:

  • 1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03869294
Other Study ID Numbers ZYYY-PAC1
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Responsible Party Weijia Fang, MD, Zhejiang University
Study Sponsor Zhejiang University
Collaborators Not Provided
Investigators Not Provided
PRS Account Zhejiang University
Verification Date February 2019