Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS

February 27, 2024 updated by: Min-Hee Ryu, Asan Medical Center

Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)

multi-center, prospective, randomized, open-label phase III

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB (by AJCC 6th edition) gastric cancer with at least one additional risk factor (additional risk factors for recurrence include age >65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).

Study Type

Interventional

Enrollment (Estimated)

870

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Sub-Investigator:
          • Ryoo Back-Yeol, MD,PhD
        • Sub-Investigator:
          • Ryu Min-Hee, MD,PhD
        • Sub-Investigator:
          • Park Sook-Ryun, MD,PhD
        • Sub-Investigator:
          • Nam Byung-Ho
        • Sub-Investigator:
          • Yook Jeong-Hwan, MD,PhD
        • Sub-Investigator:
          • Yoo Moon-Won
        • Sub-Investigator:
          • Kim Bum-Soo
        • Contact:

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

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Curatively resected gastric or gastroesophageal junction adenocarcinoma
  • Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor for recurrence (additional risk factors for recurrence include age >65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion).
  • Age: 18 -74years
  • ECOG performance status: 0-2
  • Adequate bone marrow function (ANC >1,500/uL, Platelets 100,000/uL, and Hb > 8.0 g/dL)
  • Adequate renal function (serum creatinine < 1.5 mg/dL)
  • Adequate hepatic function (bilirubin < 1.5 mg/dL, ALT and AST < 3 times upper limit of normal)
  • Written informed consent

Exclusion Criteria:

  • Pregnant or lactating women.
  • Women of childbearing potential with either a positive pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study medication and until 3 months after discontinuation of the study medication.
  • Any evidence of metastatic disease (including presence of tumor cells in the ascites).
  • Previous chemotherapy or radiotherapy for the currently treated gastric cancer.
  • No recovery from serious complications of gastrectomy.
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • Clinically significant (i.e. active) cardiac disease: e.g. unstable angina, symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 6 months.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
  • Organ allografts requiring immunosuppressive therapy.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before randomization.
  • Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
  • Positive serologic test for HIV

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Drug: capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Other Names:
  • Xeloda
No Intervention: observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence-free survival
Time Frame: 8 years
To demonstrate that capecitabine is superior to observation only (control arm) in terms of recurrence-free survival in curatively resected stage IB gastric cancer.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 8 years
To compare overall survival in the capecitabine arm compared with the control arm.
8 years
Safety profiles
Time Frame: 8years
Toxicity profiles will be assessed with the patient 28 +/- 3 days after the last intake of study medication is required. (treatment arm only)
8years

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Ulsan University Hospital
Seoul National University Bundang Hospital
Gachon University Gil Medical Center
Ajou University School of Medicine
Kyungpook National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Boramae Hospital
Gangnam Severance Hospital
Kangbuk Samsung Hospital
Hallym University Medical Center
Kyung Hee University Hospital
Inje University Haeundae Paik Hospital

Investigators

  • Principal Investigator: Min-Hee Ryu, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 19, 2013

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimated)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC1301

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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