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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

Phase 3
20 Years
Open (Enrolling)
Gastric Carcinoma Stage IV

Thank you

Trial Information

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

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

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

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)

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

6 months after treatment

Safety Issue:


Principal Investigator

Sung Yong Oh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dong-A University Hospital


Korea: Food and Drug Administration

Study ID:

KCSG ST12-05



Start Date:

December 2012

Completion Date:

December 2018

Related Keywords:

  • Gastric Carcinoma Stage IV
  • Carcinoma
  • Stomach Neoplasms