XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Dong-A University Hospital
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital
ClinicalTrials.gov Identifier:
NCT01748851
First received: December 9, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Gastric Carcinoma Stage IV
Drug: XELOX
Drug: FOLFOX
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dong-A University Hospital:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: every 6 weeks up to 6 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 3 years later initial study start ] [ Designated as safety issue: No ]
  • performance status (quality of life) [ Time Frame: Every 6 weeks up to 1 year ] [ Designated as safety issue: Yes ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.


Estimated Enrollment: 438
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
Drug: FOLFOX
5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2
Other Name: 5-FU

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748851

Contacts
Contact: SUNG YONG OH, M.D. +82-51-240-2808 drosy@dau.ac.kr
Contact: HYE-WON RYU, RN +82-51-240-5044 dongahicrc@hanmail.net

Locations
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Sung Yong Oh, M.D.    +82-51-240-2808    drosy@dau.ac.kr   
Sponsors and Collaborators
Dong-A University Hospital
Investigators
Principal Investigator: Sung Yong Oh, M.D. Dong-A University Hospital
  More Information

No publications provided

Responsible Party: Sung Yong Oh, Associate Professor, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT01748851     History of Changes
Other Study ID Numbers: KCSG ST12-05, ML27924
Study First Received: December 9, 2012
Last Updated: December 11, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014