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

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ClinicalTrials.gov Identifier: NCT01917552
Recruitment Status : Recruiting
First Posted : August 6, 2013
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
Ulsan University Hospital
Seoul National University Bundang Hospital
Gangnam Severance Hospital
Seoul National University Boramae Hospital
Ajou University School of Medicine
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Hallym University Medical Center
Inje University
Kyung Hee University Hospital
Gachon University Gil Medical Center
Kangbuk Samsung Hospital
Korea University Guro Hospital
Kyungpook National University Hospital
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Brief Summary:
multi-center, prospective, randomized, open-label phase III

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: capecitabine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)
Study Start Date : November 2013
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: Xeloda

No Intervention: observation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 8 years ]
    To compare overall survival in the capecitabine arm compared with the control arm.

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917552


Contacts
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Contact: Kang Yoon-Koo, MD, PhD 82-2-3010-3230 ykkang@amc.seoul.kr
Contact: Ryu Min-Hee, MD, PhD 82-2-3010-5935 miniryu@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Kang Yoon-Koo, MD, PhD    82-2-3010-3230    ykkang@amc.seoul.kr   
Contact: Ryu Min-Hee, MD, PhD    82-2-3010-5935    miniryu@amc.seoul.kr   
Principal Investigator: Kang Yoon-Koo, MD,PhD         
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: Kim Byung-Sik         
Sub-Investigator: Yook Jeong-Hwan, MD,PhD         
Sub-Investigator: Yoo Moon-Won         
Sub-Investigator: Kim Bum-Soo         
Sponsors and Collaborators
Asan Medical Center
Ulsan University Hospital
Seoul National University Bundang Hospital
Gangnam Severance Hospital
Seoul National University Boramae Hospital
Ajou University School of Medicine
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Hallym University Medical Center
Inje University
Kyung Hee University Hospital
Gachon University Gil Medical Center
Kangbuk Samsung Hospital
Korea University Guro Hospital
Kyungpook National University Hospital
Investigators
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Principal Investigator: Kang Yoon-Koo, MD, PhD Asan Medical Center

Publications:
Park JH, Ryu MH, Kim HJ, et al. (2012). Identification of risk factors of relapse after curative surgical resection in stage I gastric cancer. ESMO 2012 annual meeting, abstr number 679.
Collett, D. Modelling Survival Data in Medical Research, Chapman & Hall (1994), Section 9.2

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01917552    
Other Study ID Numbers: AMC1301
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, adjuvant, capecitabine, gastric cancer, stage 1b
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents