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Gastric CancerPhase 3NCT02114359

Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

A Phase 3 study testing Capecitabine/cisplatin, S-1/cisplatin and Capecitabine/oxaliplatin in people with Gastric Cancer, run by Seoul National University Hospital at 14 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Capecitabine/cisplatin, S-1/cisplatin and Capecitabine/oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
14 sitesSouth Korea
Study dates
Feb 2014to Feb 2020
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • .Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
  • 70 yrs or older
  • Eastern Cooperative Oncology Group 0-2
  • Measurable or evaluable disease
  • Adequate major organ functions
  • Hb ≥ 9.0 g/dL
Show all 13Show fewer
  • White blood cell count ≥ 3000/μL
  • Absolute Neutrophil Count (ANC) ≥ 1500/μL [*ANC = neutrophil segs ＋ neutrophil bands]
  • Platelet ≥ 100 × 103/ μL
  • Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
  • Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
  • Life expectancy > 3month
  • Written informed consent

Who cannot join

  • Metastatic or recurrent stomach cancer other than adenocarcinoma
  • HER-2 positive
  • Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
  • Radiation therapy within the previous 2wks
  • Major surgery or trauma within the previous 4wks
  • Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
Show all 10Show fewer
  • Uncontrolled brain metastasis
  • Presence of other serious disease (cardiovascular, hepatic, infection etc.)
  • Patients who participated in other clinical trials within the previous 30days
  • Men of childbearing potential not willing to use effective means of contraception

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • Hallym University Sacred Heart Hospital

    Anyang, 431-796

  • Inje University Haeundae Paik Hospital

    Busan

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Kyungpook National University Medical Center

    Daegu, 702-210

  • Yeongnam University Medical Center

    Daegu

  • National Cancer Center

    Goyang, 410-769

  • Gachon University Gil Medical Center

    Incheon, 400-713

  • Inje University Pusan Paik Hospital

    Pusan, 614-735

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Asan Medical Center

    Seoul, 138-736

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

  • Inje University Sanggye Paik Hospital

    Seoul

  • Kangbuk Samsung Hospital

    Seoul

  • The Catholic University of Korea Uijeongbu St. Mary's Hospital

    Uijeongbu-si

Other trials in South Korea

About this study

Official title: Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study

The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.

Conditions
Gastric Cancer
Being tested
Capecitabine/cisplatin, S-1/cisplatin, Capecitabine/oxaliplatin, 5-fluorouracil/oxaliplatin, Capecitabine
Keywords
gastric cancer, elderly, chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Capecitabine/cisplatinDrug

    Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks

  • S-1/cisplatinDrug

    S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks

  • Capecitabine/oxaliplatinDrug

    Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks

  • 5-fluorouracil/oxaliplatinDrug

    5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks

  • CapecitabineDrug

    Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)

  • S-1Drug

    S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)

  • 5-fluorouracilDrug

    5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks

Study groups in NCT02114359
Study groupRoleWhat they receive
Platinum/fluoropyrimidine combination chemotherapyExperimentalNot described
Receives: Drug: Capecitabine/cisplatin; Drug: S-1/cisplatin; Drug: Capecitabine/oxaliplatin; Drug: 5-fluorouracil/oxaliplatin
Fluoropyrimidine monochemotherapyActive comparatorNot described
Receives: Drug: Capecitabine; Drug: S-1; Drug: 5-fluorouracil

What is being measured

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

  1. comparison of overall survival

    Measured: upto 3years

Secondary outcomes (4)

  1. comparison of progression-free survival

    Measured: upto 2years

  2. comparison of response rate

    Measured: upto 2years

  3. comparison of adverse events

    Measured: upto 2yrs

  4. comparison of quality of life

    Measured: upto 2years

Timeline

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

  1. First posted15 Apr 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

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
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114359
Sponsor's protocol ID
20140113/16-2014-9/021
Status last verified
Oct 2020
First submitted
9 Apr 2014
Last updated
23 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5.

    PubMed 8508349

  • Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S; Japan Clinical Oncology Group Study (JCOG9205). Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol. 2003 Jan 1;21(1):54-9. doi: 10.1200/JCO.2003.04.130.

    PubMed 12506170

  • Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. doi: 10.1200/JCO.2000.18.14.2648.

    PubMed 10894863

  • Lacave AJ, Baron FJ, Anton LM, Estrada E, De Sande LM, Palacio I, Esteban E, Gracia JM, Buesa JM, Fernandez OA, et al. Combination chemotherapy with cisplatin and 5-fluorouracil 5-day infusion in the therapy of advanced gastric cancer: a phase II trial. Ann Oncol. 1991 Nov-Dec;2(10):751-4. doi: 10.1093/oxfordjournals.annonc.a057858.

    PubMed 1801881

  • Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.

    PubMed 19153121

  • Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.

    PubMed 18282805

  • Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

    PubMed 18172173

  • 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

  • Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology. 2000 Apr;58(3):191-7. doi: 10.1159/000012099.

    PubMed 10765119

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine/cisplatin, S-1/cisplatin and Capecitabine/oxaliplatin in people with Gastric Cancer, run by Seoul National University Hospital at 14 sites 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison of overall survival (time frame: upto 3years). 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 NCT02114359, which also lists 9 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 23 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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