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

November 22, 2021 updated by: TTY Biopharm

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

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Linkou, Taiwan
        • Chang Gung Memorial Hospital_Linkou
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: S-1
single-arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free survival (RFS)
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year survival rate
Time Frame: 2 years
The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years
2 years
2-year relapse-free survival (RFS) rate
Time Frame: 2 years
the percentage of people in a study who are alive 2 years after their diagnosis or the start of treatment
2 years
safety profile
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2019

Primary Completion (ACTUAL)

October 31, 2021

Study Completion (ACTUAL)

October 31, 2021

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 25, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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