A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Primary Purpose
Resected Pancreatic Cancer, Pancreatic Cancer, Adjuvant Chemotherapy
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Resected Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with resected adenocarcinoma pancreatic cancer that was histologically verified.
- Patients with macroscopic total resection of the primary tumor, and confirmed local residual tumor classified as R0/R1.
- Absence of distant metastases and malignant ascites
- Adequate oral intake
- Age of 20 years or above
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or1
Adequate hematopoietic which is defined as below,
- White blood cell count: 3,000/mm3, ≤ 12,000/mm3
- Platelet count: 100,000/mm3
- Hemoglobin: 8.0 g/dL
- ANC: 1500/mm3
- CA19-9 ≤ 100 U/mL
- Absence used of chemotherapy or radiotherapy
- Within 10 weeks following resection of pancreatic cancer
- Written informed consent given
Exclusion Criteria:
- Patient previously received adjuvant therapy for pancreatic cancer
- Patient previously received S-1 treatment and concurrent using other fluoropyrimidine-group anti-cancer drugs, combination therapies with them (such as folinate plus Tegafur-Uracil combination therapy)
- Recurrence prior to registration
- Moderate or more severe pleural effusion or ascites upon abdominal CT
Inadequate hepatic function which is defined as below:
- Total bilirubin greater than 1.5 times the ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)greater than 2.5 times the ULN
Inadequate renal function which is defined as below:
Creatinine clearance rate (CCr) < 60 mL/min
- Heart failure of Class III (Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.) or Class IV (Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.) according to the New York Heart Association functional classification
- Other serious complications such as active peptic ulcer, paresis of intestine or any others
- Pulmonary fibrosis or interstitial pneumonia clearly observed
- Uncontrolled watery diarrhea Whether a patient has diarrhea 4 or more times a day while receiving adequate supportive therapy will be used as the indicator to determine whether watery diarrhea is inadequately controlled.
- Blood transfusion within 2 weeks prior to registration
- Myocardial infarction within 6 months following documentation of pancreatic cancer
An active infectious disease (pyrexia of 38°C or higher, etc.), including active Hepatitis B or C.
- Active HBV: HBeAg positive or HBeAg negative but HBV DNA > 2000 IU/mL.
- Active HCV: Anti-HCV Ab positive
Poorly controlled diabetes mellitus:
Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
- Participation in the study by the patient is judged difficult due to a complicating psychiatric disorder or psychological symptoms
- Patient is using drainage.
- Serious drug allergy or hypersensitivity to the ingredients of S-1
- Other malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to registration
- Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Fertile women of childbearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment.
- Man who is willing to conceive a child during the treatment period.
- On flucytosine, phenytoin or warfarin potassium treatment.
- Participation in another clinical trial with any investigational drug within 30 days prior to registration.
- Patients who were judged to be ineligible as the subjects of this study by the investigators
Sites / Locations
- Chang Gung Memorial Hospital_Linkou
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital, Taiwan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-1
Arm Description
single-arm
Outcomes
Primary Outcome Measures
Relapse-free survival (RFS)
The time from registration to the time of initial detection of relapse or death from any causewhichever came first, assessed up to 2 years
Secondary Outcome Measures
2-year survival rate
The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years
2-year relapse-free survival (RFS) rate
the percentage of people in a study who are alive 2 years after their diagnosis or the start of treatment
safety profile
The incidence and percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v5.0 grade
Full Information
NCT ID
NCT04070313
First Posted
August 20, 2019
Last Updated
November 22, 2021
Sponsor
TTY Biopharm
Collaborators
Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, Chang Gung Memorial Hospital, National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04070313
Brief Title
A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Official Title
A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Study treatment is to use TS-1 (mono-chemotherapy agent) in adjuvant setting for pancreatic cancer, which may be less clinical benefit compared to combination therapy according to current trend at investigators' discretion.
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TTY Biopharm
Collaborators
Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital, 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
5. Study Description
Brief Summary
To verify the efficacy of S-1 adjuvant chemotherapy in resectable pancreatic cancer.
Primary Endpoint: Relapse-free survival (RFS)
Secondary Endpoints: 2-year survival rate, 2-year relapse-free survival (RFS) rate, safety profile
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resected Pancreatic Cancer, Pancreatic Cancer, Adjuvant Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1
Arm Type
Experimental
Arm Description
single-arm
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
Eligible patients will receive S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 28 in a 6-week cycle.
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Description
The time from registration to the time of initial detection of relapse or death from any causewhichever came first, assessed up to 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
2-year survival rate
Description
The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years
Time Frame
2 years
Title
2-year relapse-free survival (RFS) rate
Description
the percentage of people in a study who are alive 2 years after their diagnosis or the start of treatment
Time Frame
2 years
Title
safety profile
Description
The incidence and percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v5.0 grade
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with resected adenocarcinoma pancreatic cancer that was histologically verified.
Patients with macroscopic total resection of the primary tumor, and confirmed local residual tumor classified as R0/R1.
Absence of distant metastases and malignant ascites
Adequate oral intake
Age of 20 years or above
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or1
Adequate hematopoietic which is defined as below,
White blood cell count: 3,000/mm3, ≤ 12,000/mm3
Platelet count: 100,000/mm3
Hemoglobin: 8.0 g/dL
ANC: 1500/mm3
CA19-9 ≤ 100 U/mL
Absence used of chemotherapy or radiotherapy
Within 10 weeks following resection of pancreatic cancer
Written informed consent given
Exclusion Criteria:
Patient previously received adjuvant therapy for pancreatic cancer
Patient previously received S-1 treatment and concurrent using other fluoropyrimidine-group anti-cancer drugs, combination therapies with them (such as folinate plus Tegafur-Uracil combination therapy)
Recurrence prior to registration
Moderate or more severe pleural effusion or ascites upon abdominal CT
Inadequate hepatic function which is defined as below:
Total bilirubin greater than 1.5 times the ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)greater than 2.5 times the ULN
Inadequate renal function which is defined as below:
Creatinine clearance rate (CCr) < 60 mL/min
Heart failure of Class III (Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.) or Class IV (Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.) according to the New York Heart Association functional classification
Other serious complications such as active peptic ulcer, paresis of intestine or any others
Pulmonary fibrosis or interstitial pneumonia clearly observed
Uncontrolled watery diarrhea Whether a patient has diarrhea 4 or more times a day while receiving adequate supportive therapy will be used as the indicator to determine whether watery diarrhea is inadequately controlled.
Blood transfusion within 2 weeks prior to registration
Myocardial infarction within 6 months following documentation of pancreatic cancer
An active infectious disease (pyrexia of 38°C or higher, etc.), including active Hepatitis B or C.
Active HBV: HBeAg positive or HBeAg negative but HBV DNA > 2000 IU/mL.
Active HCV: Anti-HCV Ab positive
Poorly controlled diabetes mellitus:
Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
Participation in the study by the patient is judged difficult due to a complicating psychiatric disorder or psychological symptoms
Patient is using drainage.
Serious drug allergy or hypersensitivity to the ingredients of S-1
Other malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to registration
Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Fertile women of childbearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment.
Man who is willing to conceive a child during the treatment period.
On flucytosine, phenytoin or warfarin potassium treatment.
Participation in another clinical trial with any investigational drug within 30 days prior to registration.
Patients who were judged to be ineligible as the subjects of this study by the investigators
Facility Information:
Facility Name
Chang Gung Memorial Hospital_Linkou
City
Linkou
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital, Taiwan
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
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