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Gastric CancerPhase 3NCT00400179

A Safety and Efficacy Study in Patients With Gastric Cancer

A Phase 3 study testing S-1/Cisplatin and 5-FU/cisplatin in people with Gastric Cancer, run by Taiho Oncology, Inc. at 33 sites in 2 countries.

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

This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. 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 5-FU/cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,053 participants
Where
33 sitesin 2 countries
Study dates
May 2005to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
  • Has given written informed consent
  • Has histologically confirmed, unresectable, locally advanced (Stage IV) or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction
  • Has measurable or evaluable but non-measurable disease, defined as follows:
  • Measurable Disease - Patients with measurable disease as defined by RECIST criteria, i.e., the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter >_ 20 mm using conventional techniques or >_ 10 mm using spiral Computed Tomography (CT)scan. Locally recurrent disease (other than primary) is accepted if there is at least one measurable lesion (i.e. peritoneal mass, lymph node, etc.)
  • Evaluable but Non-measurable Disease - Patients with all lesions below the limits defined above for measureable disease (i.e., longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT) excluding those patients with only a primary lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardia effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis < 10 mm in diameter with conventional imaging techniques.
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  • No prior palliative chemotherapy is permitted. Adjuvant and /or neo-adjuvant chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or neo-adjuvant therapy and first recurrence. This does not qualify as 1st line therapy.
  • Is able to take medications orally
  • Is >_ 18 years of age
  • Is at least 3 weeks from prior major surgery
  • Is at least 4 weeks from prior radiotherapy
  • Has a ECOG performance status 0 to 1
  • Has adequate organ function as defined by the following criteria:
  • AST (SGOT) and ALT (SGPT) <_ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) <_ 5 x ULN
  • Total serum bilirubin of <_ 1.5 x ULN
  • Absolute granulocyte count of >_ 1,500/mm (i.e. >_ 1.5 x 10/L by International Units (IU)
  • Platelet count >_ 100,000/mm (IU: >_ 100 x 10/L
  • Hemoglobin value of >_ 9.0 g/dL
  • Calculated creatinine clearance >_ 60 mL/min (Cockcroft-Gault formula)
  • Is willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Who cannot join

  • Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
  • Has had a treatment with any of the following within the specified timeframe prior to study drug administration:
  • Any prior palliative chemotherapy or any previous therapy for malignancy, including any chemotherapy, immunotherapy, biologic or hormonal therapy, within the past 5 years.
  • Adjuvant or neo-adjuvant therapy within the past 12 months
  • Concurrent treatment with any investigational anti-cancer agent
  • Prior cisplatin as neo-adjuvant and /or adjuvant chemotherapy with cumulative dose > 300 mg/m
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  • > 25% of marrow-bearing bone radiated
  • Concurrent treatment with an investigational agent or within 30 days from randomization
  • Concurrent enrollment in another clinical study
  • Has a serious illness or medical condition(s) including, but not limited to the following:
  • Known brain or leptomeningeal metastases
  • Uncontrolled ascites requiring drainage at least twice a week
  • Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer
  • Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV
  • Chronic nausea, vomiting or diarrhea
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS-related illness
  • Psychiatric disorder that may interfere with consent and/or protocol compliance
  • Known neuropathy, Grade 2 or higher
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgement of the Investigator would make the patient inappropriate for entry into this study
  • Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
  • Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity)
  • Allopurinol (may diminish S-1 activity
  • Phenytoin (S-1 may enhance phenytoin activity)
  • Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity)
  • Is receiving concomitant treatment with drugs interacting with 5-FU:
  • Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole(may enhance 5-FU activity)
  • Allopurinol (may diminish 5-FU activity)
  • Phenytoin (5-FU may enhance phenytoin activity)
  • Is receiving concomitant treatment with drugs interacting with cisplatin:
  • Phenytoin (cisplatin may diminish phenytoin activity)
  • Aminoglycosides (should be avoided within 8 days after cisplatin administration)
  • Ethyol (may diminish cisplatin activity
  • Is a pregnant or lactating female
  • Has known hypersensitivity to 5-FU or cisplatin
  • Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients)

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States32 sites

  • AHS Lovelace Medical Group,LLC

    Albuquerque, New Mexico, 87102

  • New Mexico Cancer Center Associates

    Albuquerque, New Mexico, 87106

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • Saint Joseph Medical Center

    Burbank, California, 91505

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Associates in Oncology and Hematology

    Chattanooga, Tennessee, 37404

  • Lexington Oncology Associates

    Chattanooga, Tennessee, 37404

  • Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1470

  • St. Lukes Cancer Care Center

    Duluth, Minnesota, 55802

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • Dr. Ronald Yanagihara

    Gilroy, California, 95020

  • Hoo Chun, MD

    Hawthorne, New York, 10532

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Center

    Huntsville, Alabama, 35801

  • Western Hematology/Oncology

    Lakewood, Colorado, 80215

  • Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Oncology and Hematology

    Metairie, Louisiana, 70006

  • New Bern Cancer Care

    New Bern, North Carolina, 28560

  • Hematology/Oncology Associates of Rockland

    New City, New York, 10956

  • Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Saint Francis Memorial Hospital

    San Francisco, California, 94109

  • Premiere Oncology

    Santa Monica, California, 90404

  • Neuroscience Center

    St Louis, Missouri, 63110

  • St. Louis University Cancer Center

    St Louis, Missouri, 63110

  • Alexandar Rosemurgy

    Tampa, Florida, 33606

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Canada1 site

  • CHUM Hopital Saint-Luc

    Montreal, Quebec, H2X3J4

Other trials in Canada

About this study

Official title: An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease

This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.

Conditions
Gastric Cancer
Being tested
S-1/Cisplatin, 5-FU/cisplatin
Keywords
Gastric Cancer
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-1/CisplatinDrug

    In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.

    Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

  • 5-FU/cisplatinDrug

    In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

Study groups in NCT00400179
Study groupRoleWhat they receive
AActive comparatorIn Arm A, S-1 25 mg/m² was administered orally BID from Day 1 through Day 21 followed by a recovery period from Days 22 through Day 28. On Day 1, the morning dose of S-1 was administered before cisplatin 75 mg/m2 administration as a 1- to 3-hour IV infusion. This regimen was repeated every 4 weeks. S-1 was administered one hour before or one hour after a meal with a glass of water (approximately 100 mL).
Receives: Drug: S-1/Cisplatin
BActive comparatorIn Arm B, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion (CIV) over 120 hours (on Days 1 through 5). This regimen was repeated every 4 weeks. 5-FU CIV followed cisplatin infusion on Day 1. All 5-FU used in this study was commercially available product.
Receives: Drug: 5-FU/cisplatin

What is being measured

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

  1. Median Survival

    Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.

    Measured: The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.

    Measured: Data cutoff was 07 March 2008 (12 months after last patient randomized).

  2. Duration of Response (DR)

    Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.

    Measured: Data cutoff was 07 March 2008 (12 months after last patient was randomized).

  3. Progression-free Survival (PFS)

    The time from randomization to date of first documented PD or date of death, whichever occurred first.

    Measured: From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

  4. Time to Treatment Failure (TTF)

    The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.

    Measured: From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.

Timeline

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

  1. First posted16 Nov 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2008
  4. Study completionApr 2008

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
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00400179
Sponsor's protocol ID
TPU S-1301
Status last verified
Aug 2024
First submitted
30 Jun 2005
Last updated
19 Sep 2024
Data monitoring committee
No

Publications

  • Bodoky G, Scheulen ME, Rivera F, Jassem J, Carrato A, Moiseyenko V, Vynnychenko I, Prausova J, Van Laethem JL, Cascinu S, Ajani JA. Clinical Benefit and Health-Related Quality of Life Assessment in Patients Treated with Cisplatin/S-1 Versus Cisplatin/5-FU: Secondary End Point Results From the First-Line Advanced Gastric Cancer Study (FLAGS). J Gastrointest Cancer. 2015 Jun;46(2):109-17. doi: 10.1007/s12029-014-9680-1.

    PubMed 25707610

  • Ajani JA, Buyse M, Lichinitser M, Gorbunova V, Bodoky G, Douillard JY, Cascinu S, Heinemann V, Zaucha R, Carrato A, Ferry D, Moiseyenko V. Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: Results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study. Eur J Cancer. 2013 Nov;49(17):3616-24. doi: 10.1016/j.ejca.2013.07.003. Epub 2013 Jul 27.

    PubMed 23899532

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S-1/Cisplatin and 5-FU/cisplatin in people with Gastric Cancer, run by Taiho Oncology, Inc. at 33 sites in 2 countries.

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 20 inclusion and 35 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Survival (time frame: The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).). 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 NCT00400179, which also lists 2 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 19 Sep 2024.

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