RecruitingNCT01917552Updated Feb 28, 2024

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

A Phase 3 interventional study of capecitabine in Gastric Cancer, sponsored by Asan Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Asan Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

Started Aug 2013; still recruiting 13 years 1 month later.

Phase: Phase 3
Study type: Interventional
Enrollment: 870
Allocation: Randomized
Ages: 18 Years to 74 Years
Sex: All

Study summary

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

Read the 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).

Conditions studied

Gastric Cancer

Browse trials for

Stomach Neoplasms 2,851

Keywords

Gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, adjuvant, capecitabine, gastric cancer, stage 1b

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 870 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 870 participants (estimated)

Study arms

Experimental
capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Drug: capecitabine
No intervention
observation

Interventions

Drugcapecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Also known as: Xeloda

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Asan Medical Center
Seoul, Songpa-gu 138-736, Korea, Republic of
- Min-Hee Ryu, MD, PhD · Contact · miniryu@amc.seoul.kr · +82230105935
- Ryu Min-Hee, MD, PhD · Contact · miniryu@amc.seoul.kr · 82-2-3010-5935
- 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 · Sub investigator
Recruiting

References and documents

Publications

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. PubMed 16145066 ↗
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. PubMed 22226517 ↗
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. PubMed 9690942 ↗
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. PubMed 19474385 ↗
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. PubMed 20625131 ↗
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. PubMed 10600095 ↗
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. PubMed 18665164 ↗
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. PubMed 9440756 ↗
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. Erratum In: N Engl J Med. 2008 May 1;358(18):1977. PubMed 17978289 ↗
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. PubMed 22010012 ↗
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. PubMed 1579757 ↗
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. PubMed 25614467 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01917552
Lead sponsor: Asan Medical Center
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 Haeundae Paik Hospital, Kyung Hee University Hospital, Gachon University Gil Medical Center, Kangbuk Samsung Hospital, Kyungpook National University Hospital
Responsible party: Min-Hee Ryu (Professor, Asan Medical Center) — Principal investigator
First posted: Aug 6, 2013
Start date: Aug 19, 2013
Primary completion: Aug 1, 2026 (estimated)
Completion: Aug 1, 2026 (estimated)
Last update: Feb 28, 2024

Study contacts

Min-Hee Ryu, MD, PhD

Contact

miniryu@amc.seoul.kr

+82230105935

Hyung-Don Kim, M.D.,Ph.D

Contact

kimhdmd@amc.seoul.kr

+82230100236

Min-Hee Ryu, MD, PhD

principal investigator · Asan Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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