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XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748851
Recruitment Status : Terminated (Poor enrollment of patients)
First Posted : December 13, 2012
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

Brief Summary:
The purpose of this study is to identify the non-inferiority of the combination therapy of Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic acid and Oxaliplatin in patients with advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Carcinoma Stage IV Drug: XELOX Drug: FOLFOX Phase 3

Detailed Description:

Quality assurance: Data will be collected, controlled, and monitored at the Korean Clinical Study Group (KCSG) data center.

Data will be entered throuGh the E-Case report form (CRF) (Web based data input)

Korean Clinical Study Group (KCSG) data center will do the standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management

Sample size assessment to specify the number of participants or participant years was consulted Statistical specialist. And data analysis will be also discuss with him

Expected median progression-free survival(PFS) in Xelox: 6 months total number of events required: 359 197 patients will be needed After 10% of follow-up loss, 219 patients in each arm, a total of 438 patients will be enrolled

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Capecitabine and Oxaliplatin (XELOX) in Comparison to the Combination Therapy of Fluorouracil/Folinic Acid and Oxaliplatin (FOLFOX) in Patients With AGC
Study Start Date : December 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: XELOX
Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks
capecitabine 1000mg/m2 bid po D1-D14
Other Name: Xeloda

Active Comparator: FOLFOX
Oxaliplatin 85mg/m2 + 5DW 500ml over 2hr D1 Leucovorin 400mg/m2 + 5DW 500ml over 2hr D1 5-Fluorouracil (5-FU) 400mg/m2 IV PUSH D1 5-FU 1200mg/m2 + 5DW 1 Liter over 22hr D1-D2 Q 2weeks
5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2
Other Name: 5-FU

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: every 6 weeks up to 6 months ]
  2. overall survival [ Time Frame: 3 years later initial study start ]
  3. performance status (quality of life) [ Time Frame: Every 6 weeks up to 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age :older than 20
  2. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period). (RECIST v1.1)

    *but, patients who does not have measureable lesion with metastatic resected M1 lymph node or bone metastasis or ascites could be enrolled.

  3. No prior palliative chemotherapy (relapse 1 year later after end of adjuvant treatment available)
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
  5. The following laboratory test results:

    ① absolute neutrophil count (ANC) ≥1,500/micro Liter (uL), Platelet ≥ 100,000/uL,

    ② aspartate aminotransferase (AST) ≤ 3 x Upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3 x ULN , Total bilirubin ≤ 2.0 mg/dL (in case of liver metastasis, 5 x ULN of AST, ALT)

    ③ Creatinine ≤ 1.5 mg/dL

  6. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

  1. HER-2 Positive patients
  2. Any other malignancies within the past 2 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  3. Subjects who received radiotherapy within 4 weeks prior to randomization
  4. Subjects who have chronic or acute infection need to treatment
  5. Subjects who received major operation within 4 weeks prior to randomization
  6. patients with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months.
  7. patient with epilepsy or psychiatric problem including central nervous system(CNS) metastasis.
  8. Subjects who not be able to ingestion or have a malabsorption disorder
  9. peripheral neuropathy accompany with functional loss
  10. Prior history of allergic reaction to study treatment drugs
  11. A patient with history of other clinical trial within 4 weeks
  12. A patient of childbearing potential without being tested for pregnancy at baseline for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
  13. subject who is decided by investigator decide exclusion with any other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748851

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Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University Hospital
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Principal Investigator: Sung Yong Oh, M.D. Dong-A University Hospital

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Responsible Party: Sung Yong Oh, Associate Professor, Dong-A University Hospital Identifier: NCT01748851    
Other Study ID Numbers: KCSG ST12-05
ML27924 ( Other Grant/Funding Number: Roche Korea Company )
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs