A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan
NCT ID: NCT04070313
Last Updated: 2021-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
36 participants
INTERVENTIONAL
2019-07-11
2021-10-31
Brief Summary
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* Primary Endpoint: Relapse-free survival (RFS)
* Secondary Endpoints: 2-year survival rate, 2-year relapse-free survival (RFS) rate, safety profile
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S-1
single-arm
S-1
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.
Interventions
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S-1
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients with macroscopic total resection of the primary tumor, and confirmed local residual tumor classified as R0/R1.
3. Absence of distant metastases and malignant ascites
4. Adequate oral intake
5. Age of 20 years or above
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or1
7. 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
8. CA19-9 ≤ 100 U/mL
9. Absence used of chemotherapy or radiotherapy
10. Within 10 weeks following resection of pancreatic cancer
11. Written informed consent given
Exclusion Criteria
2. 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)
3. Recurrence prior to registration
4. Moderate or more severe pleural effusion or ascites upon abdominal CT
5. 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
6. Inadequate renal function which is defined as below:
Creatinine clearance rate (CCr) \< 60 mL/min
7. 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
8. Other serious complications such as active peptic ulcer, paresis of intestine or any others
9. Pulmonary fibrosis or interstitial pneumonia clearly observed
10. 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.
11. Blood transfusion within 2 weeks prior to registration
12. Myocardial infarction within 6 months following documentation of pancreatic cancer
13. 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
14. Poorly controlled diabetes mellitus:
Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
15. Participation in the study by the patient is judged difficult due to a complicating psychiatric disorder or psychological symptoms
16. Patient is using drainage.
17. Serious drug allergy or hypersensitivity to the ingredients of S-1
18. Other malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to registration
19. 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.
20. Man who is willing to conceive a child during the treatment period.
21. On flucytosine, phenytoin or warfarin potassium treatment.
22. Participation in another clinical trial with any investigational drug within 30 days prior to registration.
23. Patients who were judged to be ineligible as the subjects of this study by the investigators
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
TTY Biopharm
INDUSTRY
Responsible Party
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Locations
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Chang Gung Memorial Hospital_Linkou
Linkou District, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital, Taiwan
Taipei, , Taiwan
Countries
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Other Identifiers
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TTYTG1709
Identifier Type: -
Identifier Source: org_study_id