TOF Versus SOX in Metastatic Gastric Cancer

NCT02442362 | Completed Phase 2 DMC

• 1 other identifier: CZ-GA-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor respone

  According to the RECIST guideline

  8 weeks

Secondary Outcomes (1)

• Side-effect

  8 weeks

Study Arms (2)

TOF Group

ACTIVE COMPARATOR

Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil"

Drug: paclitaxel+oxaliplatin+fluorouracil

SOX Group

EXPERIMENTAL

The patients in the SOX group received chemotherapy with 'oxaliplatin+S1'

Drug: oxaliplatin+S1

Interventions

paclitaxel+oxaliplatin+fluorouracil DRUG

Patients treated with "paclitaxel+oxaliplatin+fluorouracil": paclitaxel (135 mg/m2 iv) on day 1, oxaliplatin (100 mg/m2 iv) on day 1, fluorouracil (500 mg/m2 continuous iv) on day 1-5twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14.

Also known as: TOF regimen

TOF Group

oxaliplatin+S1 DRUG

Patients treated with "oxaliplatin+S1": oxaliplatin (130 mg/m2 iv) on day 1 and S-1 (40 mg twice/day for body surface area \< 1.25 m2 and 60 mg twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14

Also known as: SOX regimen

SOX Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically confirmed mGC (stage IV)
• ages between 20 and 80 years
• measurable or assessable lesions by imaging studies according to the RECIST guideline 21
• no prior chemotherapy except for postoperative adjuvant chemotherapy for more than 12 months before entry into the study
• Eastern Cooperative Oncology Group (ECOG) performance status score less than 3
• 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)
• estimated life expectancy more than 3 months
• no other secondary malignant tumors.

You may not qualify if:

• preexisted peripheral toxicity ≥ grade 2 of the National Cancer Institute Common Toxicity Criteria
• concurrent or prior malignancy
• central nervous system metastases
• concurrent treatment that interfered with the study evaluation
• active infection
• other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment
• having inadequate calorie and fluid intake
• pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Changping Wu, M.D.

  the First People' Hospital of Changzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: May 13, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05