Back to resultsLocally Advanced or Metastatic Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
chemotherapy: TS-1, Leucovorin and Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring in Elderly Patients
Eligibility Criteria
Inclusion Criteria:
- Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
- Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
- Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
- Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Baseline ECOG performance status is 2.
- Patients have life expectancy of at least 12 weeks.
- Patients have age 70 years.
- Patients have adequate organ function.
- Patients with biliary obstruction which is adequate drained before enrollment are eligible.
- Patients agree to have an indwelling venous catheter implanted.
- Women or men of reproductive potential should agree to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign written informed consents.
Exclusion Criteria:
- Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
- Patients with metastatic lesion in central nervous system.
- Patients with active infection.
- Patients with active cardiopulmonary disease or history of ischemic heart disease.
- Patients who have peripheral neuropathy > grade I of any etiology.
- Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
- Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.
Sites / Locations
- China Medical University Hospital
- Chang-Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biweekly TS-1, Leucovorin and Gemcitabine (GSL)
Arm Description
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
The progression-free survival time for elderly patients with advanced pancreatic cancer
Secondary Outcome Measures
Overall tumor response rate
Full Information
NCT ID
NCT03559348
First Posted
April 18, 2018
Last Updated
July 28, 2022
Sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03559348
Brief Title
Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Official Title
Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
National Taiwan University Hospital, China Medical University Hospital, Kaohsiung Medical University, Chang Gung Memorial Hospital, National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Multiple centers, uncontrolled, open-label, non-randomized single-arm study
Detailed Description
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)
Secondary objectives:
Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
in Elderly Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biweekly TS-1, Leucovorin and Gemcitabine (GSL)
Arm Type
Experimental
Arm Description
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle
Intervention Type
Drug
Intervention Name(s)
chemotherapy: TS-1, Leucovorin and Gemcitabine
Intervention Description
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The progression-free survival time for elderly patients with advanced pancreatic cancer
Time Frame
up to 5.0 months
Secondary Outcome Measure Information:
Title
Overall tumor response rate
Time Frame
up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
Baseline ECOG performance status is 2.
Patients have life expectancy of at least 12 weeks.
Patients have age 70 years.
Patients have adequate organ function.
Patients with biliary obstruction which is adequate drained before enrollment are eligible.
Patients agree to have an indwelling venous catheter implanted.
Women or men of reproductive potential should agree to use an effective contraceptive method.
All patients must be informed of the investigational nature of this study and must sign written informed consents.
Exclusion Criteria:
Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
Patients with metastatic lesion in central nervous system.
Patients with active infection.
Patients with active cardiopulmonary disease or history of ischemic heart disease.
Patients who have peripheral neuropathy > grade I of any etiology.
Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Locally Advanced or Metastatic Pancreatic Adenocarcinoma
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