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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: S-1
single-arm
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TTY Biopharm

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital, Taiwan
National Cheng-Kung University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTYTG1709

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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