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Gastric CancerPhase 3NCT01917552

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

A Phase 3 study testing capecitabine in people with Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

multi-center, prospective, randomized, open-label phase III Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Gastric Cancer
What is being tested?
capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
870 participants
Where
1 siteSouth Korea
Study dates
19 Aug 2013to 1 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Min-Hee Ryu, MD, PhD contact

+82230105935

miniryu@amc.seoul.kr

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

+82230100236

kimhdmd@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

    Min-Hee Ryu, MD, PhD, +82230105935, miniryu@amc.seoul.kr

    Ryu Min-Hee, MD, PhD, 82-2-3010-5935, miniryu@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

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)

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
Gastric Cancer
Being tested
capecitabine
Keywords
Gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, adjuvant, capecitabine, gastric cancer, stage 1b
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    Also called Xeloda

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

Study groups in NCT01917552
Study groupRoleWhat they receive
capecitabineExperimentalcapecitabine 1250 milligram (mg) / m² po bid (D1-14)
Receives: Drug: capecitabine
observationNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 years

Secondary outcomes (2)

  1. overall survival

    To compare overall survival in the capecitabine arm compared with the control arm.

    Measured: 8 years

  2. 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)

    Measured: 8years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study start19 Aug 2013
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
870 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917552
Sponsor's protocol ID
AMC1301
Status last verified
Feb 2024
First submitted
30 Jul 2013
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine in people with Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Min-Hee Ryu, MD, PhD (+82230105935, miniryu@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence-free survival (time frame: 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917552, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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