TOF Versus SOX in Metastatic Gastric Cancer

May 12, 2015 updated by: Liangrong Shi, The First People's Hospital of Changzhou

Paclitaxel/Oxaliplatin/Fluorouracil (TOF) Regimen Versus S-1/Oxaliplatin (SOX) Regimen Metastatic Gastric Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric carcinoma ranks second among the most common causes of cancer deaths worldwide, with especial high prevalence in Asia . Gastric cancer is the third most common cancer in China and the incidence rate and death rate of gastric cancer in Jiangsu Province are especially higher than the national average. Surgical resection is the preferred treatment for gastric cancer, but approximately two-thirds of patients have metastatic disease at the time of diagnosis. Prognosis in these patients is poor, with a median survival time of 3 to 5 months without treatment and a reported 5-year survival rate of 9.4%. Even receiving curative gastrectomy, 60% of mGC patients develop local recurrences or distant metastasis.

For advanced-stage patients with inoperable gastric tumors, chemotherapy is considered the most effective treatment option and the efficacy of postoperative chemotherapy has been acknowledged. However, a worldwide consensus on standard chemotherapy regimens has yet to be established. The prognosis has gradually improved because of advances in chemotherapy regimens, but is not yet satisfactory.Among various regimens, the combinations of paclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen have become two important ones.

Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle arrest and apoptosis. The response rate of GC patients to paclitaxel is 20%-25%. Oxaliplatin is a third-generation diaminocyclohexane platinum compound which has a wide range of antitumor activities, appearing to have a better safety profile than cisplatin. The response rate of mGC patients to FOLFOX-4 regimen is 38%-43%. S-1 is an oral anti-cancer agent composed of tegafur, 5-chloro-2,4-dihydroxypyridine, and oteracil potassium. The applying of S-1 as adjuvant chemotherapy for mGC can improve the overall survival (OS) and relapse-free survival. A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based chemotherapy in mGC. S-1 plus oxaliplatin (SOX) have showed non-inferiority to S-1 plus cisplatin in PFS and that the treatment was well tolerated in patients with mGC.

No study is available comparing the efficacy and safety of TOF and SOX regimens. So the investigators performed the present randomized, controlled study to compare the efficacy and safety of the two regimens in mGC patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TOF Group
Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil"
Drug: paclitaxel+oxaliplatin+fluorouracil
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.
Other Names:
  • TOF regimen
Experimental: SOX Group
The patients in the SOX group received chemotherapy with 'oxaliplatin+S1'
Drug: oxaliplatin+S1
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
Other Names:
  • SOX regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor respone
Time Frame: 8 weeks
According to the RECIST guideline
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side-effect
Time Frame: 8 weeks
Safety was evaluated according to the NCI-CTC
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Changzhou

Investigators

  • Study Director: Changping Wu, M.D., the First People' Hospital of Changzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZ-GA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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