Clincosm LogoSign in Get a demo

XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

Sponsor
Dong-A University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01748851
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
21
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
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 :
Dec 1, 2012
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: XELOX

Capecitabine 1000mg/m2 bid D1-D14 Oxaliplatin 130mg/m2 + 5% Dextrose water (5DW) 500ml over 2hour D1 Q 2weeks

Drug: XELOX
capecitabine 1000mg/m2 bid po D1-D14
Other Names:
  • 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

    Drug: FOLFOX
    5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2
    Other Names:
  • 5-FU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [6 months after treatment]

    Secondary Outcome Measures

    1. Response rate [every 6 weeks up to 6 months]

    2. overall survival [3 years later initial study start]

    3. performance status (quality of life) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    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.

    1. No prior palliative chemotherapy (relapse 1 year later after end of adjuvant treatment available)

    2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2

    3. 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dong-A University Hospital Busan Korea, Republic of 602-715

    Sponsors and Collaborators

    • Dong-A University Hospital

    Investigators

    • Principal Investigator: Sung Yong Oh, M.D., Dong-A University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sung Yong Oh, Associate Professor, Dong-A University Hospital
    ClinicalTrials.gov Identifier:
    NCT01748851
    Other Study ID Numbers:
    • KCSG ST12-05
    • ML27924
    First Posted:
    Dec 13, 2012
    Last Update Posted:
    Nov 4, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Nov 4, 2014