A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04070313
• Other study ID #: TTYTG1709
• Status: Terminated
• Phase: Phase 2
• Start date: July 11, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: TTY Biopharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Pancreatic Cancer
• Pancreatic Neoplasms
• Resected Pancreatic Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital_Linkou	Linkou
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital, Taiwan	Taipei

Sponsors (5)

Lead Sponsor	Collaborator
TTY Biopharm	Chang Gung Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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 years
Secondary	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	2 years
Secondary	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	2 years