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Gastric CancerPhase 3SOPPNCT01671449

S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for Advanced Gastric Cancer

A Phase 3 study testing S-1, Cisplatin and Oxaliplatin in people with Gastric Cancer, run by Min-Hee Ryu at 9 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

A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
S-1, Cisplatin and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
9 sitesSouth Korea
Study dates
Dec 2012to Oct 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent before the enrollment
  • Age ≥18 years old
  • Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients able to swallow food and drugs
  • At least one measurable or evaluable lesion according to RECIST criteria version 1.1
Show all 12Show fewer
  • Adequate bone, hepatic, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first administration of study drugs
  • Absolute neutrophil count (ANC) ≥ 1,500/ uL, platelet ≥ 100,000/ uL, haemoglobin (Hb) ≥ 9.0 g/dl,
  • Serum creatinine ≤ 1.5 mg/dL (If serum creatinine is greater than 1.5 mg/dL, creatinine clearance [Ccr] should be 60 mL/min or greater. Ccr is calculated by Cockcroft-Gault formula or 24hr urine collection)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST/ALT levels ≤ 3.0 x ULN (AST/ALT levels ≤ 5.0 x ULN for patients with liver involvement of their cancer)
  • In patients who received adjuvant or neoadjuvant chemotherapy, completion of systemic chemotherapy 6 months before the study enrollment, and no previous administration of platinum derivatives
  • Estimated life expectancy of more than 3 months

Who cannot join

  • Other histologic types than adenocarcinoma
  • Recurrence within 24 weeks following completion of adjuvant chemotherapy
  • R1 gastrectomy (i.e., microscopic residual disease)
  • History of another malignancy within the last five years from the day of written informed consent except cured basal cell carcinoma of skin and cured carcinoma in situ of uterine cervix
  • Radiotherapy within 4 weeks after randomization
  • History of significant neurologic or psychiatric disorders, and presence or history of CNS metastasis
Show all 27Show fewer
  • Major surgery within 4 weeks before study entry, or insufficient recovery from major surgery (except the patients who received only open and closure or biopsy)
  • Other serious illness or medical conditions as follows;
  • Any following conditions occurred within 6 months before study entry: myocardial infarction, severe/unstable angina, bypass surgery for coronary artery/peripheral artery, congestive heart failure (NYHA class III or IV), cerebral infarction or transient ischemic attack
  • Conduction abnormality such as 2nd degree or greater AV block or severe arrhythmia that requires medical treatments (right bundle branch block (RBBB) is eligible, but left bundle branch block (LBBB) is not.)
  • Uncontrolled hypertension
  • Liver cirrhosis (Child Pugh Class B or greater)
  • Interstitial pneumonia, pulmonary fibrosis
  • Active viral hepatitis B
  • Uncontrolled diabetes mellitus
  • Uncontrolled ascites or pleural effusion
  • Uncontrolled active infection or sepsis
  • Administration of medications which may have potentially pharmacokinetic interaction with S-1, cisplatin, and oxaliplatin
  • Flucytosine, a fluorinated pyrimidine antifungal agent
  • Anti-viral agents, such as sorivudine, and brivudine, or chemical similar drugs
  • Warfarin (except, low dose warfarin for the purpose of prophylaxis), phenprocoumon
  • Phenytoin
  • Allopurinol
  • Participation to other clinical trials or administration of other investigational drugs within 30 days before the randomisation
  • Pregnant or lactating women
  • Women or men of child bearing potential not employing adequate contraception during study treatments or until the 3 months after the end of study treatments
  • Ineligible for the study at the discretion of investigators

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Seoul National University Bundang Hospital

    Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707

  • Dongnam Institute of Radiological and Medical Sciences

    Busan, 619-953

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-711

  • Yeungnam University Medical Center

    Daegu, 705-717

  • Gangneung Asan Hospital

    Gangneung-si, 210-711

  • Chonnam National University Hwasun Hospital

    Hwasun-eup, Hwasun-gun, Jeollanam-do, 519-763

  • National Cancer Center

    Ilsan, Gyeonggi-do

  • Seoul St. Mary's hospital of the Catholic University of Korea

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer

A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer

Conditions
Gastric Cancer
Being tested
S-1, Cisplatin, Oxaliplatin
Keywords
Gastric cancer, S-1, Cisplatin, Oxaliplatin
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • S-1Drug

    Also called TS-1

    S-1 : 40 mg/m2, twice daily, Day 1-14

  • CisplatinDrug

    60 mg/m2/day Day 1

  • OxaliplatinDrug

    Also called Pleoxin

    130 mg/m2/day Day 1

Study groups in NCT01671449
Study groupRoleWhat they receive
S-1 plus CisplatinActive comparator* S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area) : If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15. * Cisplatin: 60 mg/ m2/day, i.v., day 1 * Every 3 weeks
Receives: Drug: S-1; Drug: Cisplatin
S-1 plus OxaliplatinExperimental* S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area) : If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15. * Oxaliplatin: 130 mg/ m2/day, i.v., day 1 * Every 3 weeks
Receives: Drug: S-1; Drug: Oxaliplatin

What is being measured

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

  1. Progression-free survival

    The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.

    Measured: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (4)

  1. Overall survival

    Overall survival is defined as the time from randomization to death due to any cause.

    Measured: From date of randomization to death from any cause, assessed up to 3 years

  2. Response rate

    Response assessment will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 every 2 cycles (6 weeks) of treatment.

    Measured: Every 6 weeks

  3. Quality of life

    Quality of life of patient will be evaluated using EUROQOL(EQ-5D). Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.

    Measured: Every 6 weeks

  4. Number of Adverse Events

    Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.

    Measured: Every 3 weeks

Timeline

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

  1. First posted23 Aug 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionOct 2014
  4. Study completionOct 2015

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
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01671449
Sponsor's protocol ID
AMC-ONCGI-1202
Acronym
SOPP
Status last verified
Nov 2015
First submitted
17 Aug 2012
Last updated
30 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Ahn YO, Park BJ, Yoo KY, Kim NK, Heo DS, Lee JK, Ahn HS, Kang DH, Kim H, Lee MS, et al. Incidence estimation of stomach cancer among Koreans. J Korean Med Sci. 1991 Mar;6(1):7-14. doi: 10.3346/jkms.1991.6.1.7.

    PubMed 1888453

  • Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. doi: 10.1038/bjc.1995.114.

    PubMed 7533517

  • Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668.

    PubMed 9093725

  • Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M. Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer. 1993 Jul 1;72(1):37-41. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-p.

    PubMed 8508427

  • Scheithauer W, Kornek G, Zek B et al. Palliative chemotherapy versus supportive care in patients with metastatic gastric cancer: A randomized trial. Second Int Conf Biol, Prev, Treatm GI Malignancy, Koln, Germany 1995;68(Abstr)

  • Comis RL, Carter SK. A review of chemotherapy in gastric cancer. Cancer. 1974 Nov;34(5):1576-86. doi: 10.1002/1097-0142(197411)34:53.0.co;2-0. No abstract available.

    PubMed 4279136

  • Kaufman S. 5-Fluorouracil in the treatment of gastrointestinal neoplasia. N Engl J Med. 1973 Jan 25;288(4):199-201. doi: 10.1056/NEJM197301252880408. No abstract available.

    PubMed 4264581

  • Schein PS, Macdonald JS, Hoth D, Wooley PV. Mitomycin C: experience in the United States, with emphasis on gastric cancer. Cancer Chemother Pharmacol. 1978;1(2):73-5. doi: 10.1007/BF00254039. No abstract available.

    PubMed 750107

  • Moertel CG, Lavin PT. Phase II-III chemotherapy studies in advanced gastric cancer. Eastern Cooperative Oncology Group. Cancer Treat Rep. 1979 Nov-Dec;63(11-12):1863-9.

    PubMed 393381

  • Lacave AJ, Wils J, Diaz-Rubio E, Clavel M, Planting A, Bleiberg H, Duez N, Dalesio O. cis-Platinum as second-line chemotherapy in advanced gastric adenocarcinoma. A phase II study of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Eur J Cancer Clin Oncol. 1985 Nov;21(11):1321-4. doi: 10.1016/0277-5379(85)90311-6.

    PubMed 4076293

  • Kambe M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T. A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancers (abstr 584). Proc Am Soc Clin Oncol 1993;12;198

  • Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J. Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer. 1994 Aug;70(2):380-3. doi: 10.1038/bjc.1994.310.

    PubMed 7914428

  • Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.

    PubMed 16782930

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S-1, Cisplatin and Oxaliplatin in people with Gastric Cancer, run by Min-Hee Ryu at 9 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 12 inclusion and 27 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Progression-free survival (time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 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 NCT01671449, which also lists 44 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 30 Nov 2015.

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