Clinical trial NCT01748851: XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastric Carcinoma Stage IV
Lead sponsor: Dong-A University Hospital
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Progression free survival
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Response rate
timeFrame: every 6 weeks up to 6 months
measure: overall survival
timeFrame: 3 years later initial study start
measure: performance status (quality of life)
timeFrame: Every 6 weeks up to 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
affiliation: Dong-A University Hospital
name: Sung Yong Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: