Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
NCT ID: NCT01917552
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
870 participants
INTERVENTIONAL
2013-08-19
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
observation
No interventions assigned to this group
Interventions
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capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Ulsan University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Gangnam Severance Hospital
OTHER
Seoul National University Boramae Hospital
OTHER
Ajou University School of Medicine
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Hallym University Medical Center
OTHER
Inje University Haeundae Paik Hospital
OTHER
Kyung Hee University Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Kangbuk Samsung Hospital
OTHER
Kyungpook National University Hospital
OTHER
Asan Medical Center
OTHER
Responsible Party
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Min-Hee Ryu
Professor
Principal Investigators
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Min-Hee Ryu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Ajani JA, Faust J, Ikeda K, Yao JC, Anbe H, Carr KL, Houghton M, Urrea P. Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol. 2005 Oct 1;23(28):6957-65. doi: 10.1200/JCO.2005.01.917. Epub 2005 Sep 6.
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
Diasio RB. Sorivudine and 5-fluorouracil; a clinically significant drug-drug interaction due to inhibition of dihydropyrimidine dehydrogenase. Br J Clin Pharmacol. 1998 Jul;46(1):1-4. doi: 10.1046/j.1365-2125.1998.00050.x.
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
Kang YK, Lee SS, Yoon DH, Lee SY, Chun YJ, Kim MS, Ryu MH, Chang HM, Lee JL, Kim TW. Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study. J Clin Oncol. 2010 Aug 20;28(24):3824-9. doi: 10.1200/JCO.2010.29.1807. Epub 2010 Jul 12.
Kolesar JM, Johnson CL, Freeberg BL, Berlin JD, Schiller JH. Warfarin-5-FU interaction--a consecutive case series. Pharmacotherapy. 1999 Dec;19(12):1445-9. doi: 10.1592/phco.19.18.1445.30897.
Lee JL, Kang YK, Kang HJ, Lee KH, Zang DY, Ryoo BY, Kim JG, Park SR, Kang WK, Shin DB, Ryu MH, Chang HM, Kim TW, Baek JH, Min YJ. A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. Br J Cancer. 2008 Aug 19;99(4):584-90. doi: 10.1038/sj.bjc.6604536. Epub 2008 Jul 29.
O'Connell MJ, Laurie JA, Kahn M, Fitzgibbons RJ Jr, Erlichman C, Shepherd L, Moertel CG, Kocha WI, Pazdur R, Wieand HS, Rubin J, Vukov AM, Donohue JH, Krook JE, Figueredo A. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol. 1998 Jan;16(1):295-300. doi: 10.1200/JCO.1998.16.1.295.
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.
Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91. doi: 10.1002/sim.4780110205.
Collett, D. Modelling Survival Data in Medical Research, Chapman & Hall (1994), Section 9.2
Park JH, Ryu MH, Kim HJ, Ryoo BY, Yoo C, Park I, Park YS, Oh ST, Yook JH, Kim BS, Kang YK. Risk factors for selection of patients at high risk of recurrence or death after complete surgical resection in stage I gastric cancer. Gastric Cancer. 2016 Jan;19(1):226-33. doi: 10.1007/s10120-015-0464-5. Epub 2015 Jan 23.
Other Identifiers
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AMC1301
Identifier Type: -
Identifier Source: org_study_id
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