Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

December 21, 2007 updated by: National Cancer Center, Korea

A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of
        • Recruiting
        • National Cancer Center Korea
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Neo Kyenong Kim, M.D.Ph.D
        • Sub-Investigator:
          • Young Iee Park, M,D.Ph.D
        • Sub-Investigator:
          • Jong Seok Lee, M.D.
        • Sub-Investigator:
          • Byung-Ho Nam, M.D.Ph.D
        • Sub-Investigator:
          • Young-Ho Yun, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
  2. Age ≥ 18 years
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
  5. No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
  6. Adequate major organ function including the following: Hematopoietic function: ANC >= 1,500/mm3, Platelet >= 100,000/mm3, Hepatic function: serum bilirubin =< 1.5 x ULN, AST/ALT levels =< 2.5 x ULN (=< 5 x ULN if liver metastases are present)Renal function: serum creatinine =< 1.5 x ULN
  7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

  1. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
  2. Patients with active (significant or uncontrolled) gastrointestinal bleeding
  3. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0

  4. Prior and/or current history of peripheral neuropathy

    • grade 1 NCI-CTCAE version 3.0
  5. Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
  6. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  7. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
  8. History of or current brain metastases
  9. Psychiatric disorder that would preclude compliance
  10. Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
  11. Subjects with reproductive potential not willing to use an effective method of contraception
  12. Lactating women
  13. Known dihydropyrimidine dehydrogenase deficiency
  14. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
  15. Major surgery within 4 weeks of start of study treatment, without complete recovery
  16. Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal.
Drug: S-1,oxaliplatin

Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.

Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
Active Comparator: B
(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
Drug: S-1,oxaliplatin

Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.

Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survial in the two treatment arms
Time Frame: During study period
During study period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity
Time Frame: During study period
During study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Center, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sook Ryun Park, M.D., National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCCCTS-07-265
  • 82-31-920-1609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings