XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

NCT01748851 | Terminated Phase 3 DMC

• 2 other identifiers: KCSG ST12-05ML27924
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Carcinoma Stage IV

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  6 months after treatment

Secondary Outcomes (3)

• Response rate

  every 6 weeks up to 6 months

• overall survival

  3 years later initial study start

• performance status (quality of life)

  Every 6 weeks up to 1 year

Study Arms (2)

XELOX

EXPERIMENTAL

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

Drug: XELOX

FOLFOX

ACTIVE COMPARATOR

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

Interventions

XELOX DRUG

capecitabine 1000mg/m2 bid po D1-D14

Also known as: Xeloda

XELOX

FOLFOX DRUG

5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2

Also known as: 5-FU

FOLFOX

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age :older than 20
• 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.
• No prior palliative chemotherapy (relapse 1 year later after end of adjuvant treatment available)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• 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
• 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.

You may not qualify if:

• HER-2 Positive patients
• Any other malignancies within the past 2 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
• Subjects who received radiotherapy within 4 weeks prior to randomization
• Subjects who have chronic or acute infection need to treatment
• Subjects who received major operation within 4 weeks prior to randomization
• 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.
• patient with epilepsy or psychiatric problem including central nervous system(CNS) metastasis.
• Subjects who not be able to ingestion or have a malabsorption disorder
• peripheral neuropathy accompany with functional loss
• Prior history of allergic reaction to study treatment drugs
• A patient with history of other clinical trial within 4 weeks
• 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.)

Sponsors & Collaborators

• Dong-A University Hospital: lead

Study Sites (1)

Dong-A University Hospital

Busan, 602-715, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

XELOX; Capecitabine; Folfox protocol; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sung Yong Oh, M.D.

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2012
• First Posted: December 13, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

KR (1)