Clinical trial NCT04070313: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Resected Pancreatic Cancer
Pancreatic Cancer
Adjuvant Chemotherapy
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Taiwan University Hospital
name: Chang Gung Memorial Hospital
name: National Cheng-Kung University Hospital
First posted: 2019-08-28
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Patients with resected adenocarcinoma pancreatic cancer that was histologically verified.
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:

1. Patient previously received adjuvant therapy for pancreatic cancer
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

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: 2 years
Secondary outcomes:
measure: 2-year survival rate
timeFrame: 2 years
measure: 2-year relapse-free survival (RFS) rate
timeFrame: 2 years
measure: safety profile
timeFrame: 2 years
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital_Linkou
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Taiwan
Study officials:
References: