TOF Versus SOX in Metastatic Gastric Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to compare the efficacy and safety of aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer (GC) patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First People's Hospital of Changzhou
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. pathologically confirmed mGC (stage IV)

2. ages between 20 and 80 years

3. measurable or assessable lesions by imaging studies according to the RECIST guideline 21

4. no prior chemotherapy except for postoperative adjuvant chemotherapy for more than 12 months before entry into the study

5. Eastern Cooperative Oncology Group (ECOG) performance status score less than 3

6. hepatic function

• total bilirubin ≤ 1.5 × the institutional upper limit of normal value, aspartate aminotransferase/alanine aminotransferase ≤ 2.5 × the institutional upper limit of normal value, and alkaline phosphatase ≤ 2.5 × the institutional upper limit of normal value

• renal function (serum creatinine level ≤ 1.5 mg/dL and creatinine clearance ≥ 50 ml/min)

• adequate bone marrow function (hemoglobin level ≥ 90 g/L, white blood cell count of 4-10×109/L, neutrophil count ≥ 2×109/L, and platelet count ≥ 100×109/L)

7. estimated life expectancy more than 3 months

8. no other secondary malignant tumors.

Exclusion Criteria:

1. preexisted peripheral toxicity ≥ grade 2 of the National Cancer Institute Common Toxicity Criteria

2. concurrent or prior malignancy

3. central nervous system metastases

4. concurrent treatment that interfered with the study evaluation

5. active infection

6. other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment

7. having inadequate calorie and fluid intake

8. pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception.