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

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917552
• Other study ID #: AMC1301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 19, 2013
• Est. completion date: August 1, 2026

Study information

• Verified date: February 2024
• Source: Asan Medical Center
• Contact: Min-Hee Ryu, MD, PhD
• Phone: +82230105935
• Email: miniryu[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 870
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• capecitabine
capecitabine 1250 milligram (mg) / m² po bid (D1-14)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (13)

Lead Sponsor

Collaborator

Asan Medical Center

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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View Citation

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. — View Citation

Collett, D. Modelling Survival Data in Medical Research, Chapman & Hall (1994), Section 9.2

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 years
Secondary	overall survival	To compare overall survival in the capecitabine arm compared with the control arm.	8 years
Secondary	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)	8years