AzTrials
AzTrials

Resected Pancreatic CancerPhase 2NCT04070313

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

A Phase 2 study testing S-1 in people with Resected Pancreatic Cancer and Pancreatic Cancer, run by TTY Biopharm at 4 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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 Read more about this study

Who is it for?
Any age
What is being tested?
S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesTaiwan
Study dates
11 Jul 2019to 31 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with resected adenocarcinoma pancreatic cancer that was histologically verified.
  • Patients with macroscopic total resection of the primary tumor, and confirmed local residual tumor classified as R0/R1.
  • Absence of distant metastases and malignant ascites
  • Adequate oral intake
  • Age of 20 years or above
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or1
Show all 15Show fewer
  • 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
  • CA19-9 ≤ 100 U/mL
  • Absence used of chemotherapy or radiotherapy
  • Within 10 weeks following resection of pancreatic cancer
  • Written informed consent given

Who cannot join

  • Patient previously received adjuvant therapy for pancreatic cancer
  • 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)
  • Recurrence prior to registration
  • Moderate or more severe pleural effusion or ascites upon abdominal CT
  • Inadequate hepatic function which is defined as below:
  • Total bilirubin greater than 1.5 times the ULN
Show all 29Show fewer
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)greater than 2.5 times the ULN
  • Inadequate renal function which is defined as below:
  • Creatinine clearance rate (CCr) < 60 mL/min
  • 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
  • Other serious complications such as active peptic ulcer, paresis of intestine or any others
  • Pulmonary fibrosis or interstitial pneumonia clearly observed
  • 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.
  • Blood transfusion within 2 weeks prior to registration
  • Myocardial infarction within 6 months following documentation of pancreatic cancer
  • 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
  • Poorly controlled diabetes mellitus:
  • Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
  • Participation in the study by the patient is judged difficult due to a complicating psychiatric disorder or psychological symptoms
  • Patient is using drainage.
  • Serious drug allergy or hypersensitivity to the ingredients of S-1
  • Other malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to registration
  • 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.
  • Man who is willing to conceive a child during the treatment period.
  • On flucytosine, phenytoin or warfarin potassium treatment.
  • Participation in another clinical trial with any investigational drug within 30 days prior to registration.
  • Patients who were judged to be ineligible as the subjects of this study by the investigators

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • Chang Gung Memorial Hospital_Linkou

    Linkou District

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital, Taiwan

    Taipei

Other trials in Taiwan

About this study

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
Being tested
S-1
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-1Drug

    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.

Study groups in NCT04070313
Study groupRoleWhat they receive
S-1Experimentalsingle-arm
Receives: Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (3)

  1. 2-year survival rate

    The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start11 Jul 2019
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Why it stopped: Study treatment is to use TS-1 (mono-chemotherapy agent) in adjuvant setting for pancreatic cancer, which may be less clinical benefit compared to combination therapy according to current trend at investigators' discretion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070313
Sponsor's protocol ID
TTYTG1709
Status last verified
Nov 2021
First submitted
20 Aug 2019
Last updated
6 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-1 in people with Resected Pancreatic Cancer and Pancreatic Cancer, run by TTY Biopharm at 4 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study treatment is to use TS-1 (mono-chemotherapy agent) in adjuvant setting for pancreatic cancer, which may be less clinical benefit compared to combination therapy according to current trend at investigators' discretion.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival (RFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in