Status:
TERMINATED
A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
Lead Sponsor:
TTY Biopharm
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Conditions:
Resected Pancreatic Cancer
Pancreatic Cancer
Eligibility:
All Genders
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04070313
Start Date
July 11 2019
End Date
October 31 2021
Last Update
December 6 2021
Active Locations (4)
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1
Chang Gung Memorial Hospital_Linkou
Linkou District, Taiwan
2
National Cheng Kung University Hospital
Tainan, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan
4
Taipei Veterans General Hospital, Taiwan
Taipei, Taiwan