TOF Versus SOX in Metastatic Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
paclitaxel+oxaliplatin+fluorouracil
oxaliplatin+S1
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TOF Group
SOX Group
Arm Description
Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil"
The patients in the SOX group received chemotherapy with 'oxaliplatin+S1'
Outcomes
Primary Outcome Measures
Tumor respone
According to the RECIST guideline
Secondary Outcome Measures
Side-effect
Safety was evaluated according to the NCI-CTC
Full Information
NCT ID
NCT02442362
First Posted
May 10, 2015
Last Updated
May 12, 2015
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02442362
Brief Title
TOF Versus SOX in Metastatic Gastric Cancer
Official Title
Paclitaxel/Oxaliplatin/Fluorouracil (TOF) Regimen Versus S-1/Oxaliplatin (SOX) Regimen Metastatic Gastric Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Changzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOF Group
Arm Type
Active Comparator
Arm Description
Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil"
Arm Title
SOX Group
Arm Type
Experimental
Arm Description
The patients in the SOX group received chemotherapy with 'oxaliplatin+S1'
Intervention Type
Drug
Intervention Name(s)
paclitaxel+oxaliplatin+fluorouracil
Other Intervention Name(s)
TOF regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin+S1
Other Intervention Name(s)
SOX regimen
Intervention Description
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
Primary Outcome Measure Information:
Title
Tumor respone
Description
According to the RECIST guideline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Side-effect
Description
Safety was evaluated according to the NCI-CTC
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changping Wu, M.D.
Organizational Affiliation
the First People' Hospital of Changzhou
Official's Role
Study Director
12. IPD Sharing Statement
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TOF Versus SOX in Metastatic Gastric Cancer
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