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Trial record 12 of 2005 for:    oxaliplatin

Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608646
Recruitment Status : Unknown
Verified May 2012 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : May 31, 2012
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE May 13, 2012
First Posted Date  ICMJE May 31, 2012
Last Update Posted Date May 31, 2012
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2012)
Objective tumor response [ Time Frame: Every eight weeks ]
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2012)
  • Overall survival [ Time Frame: Three year ]
    The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.
  • Progress-free survival [ Time Frame: one year ]
    The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.
  • Adverse event incidence [ Time Frame: One year ]
    The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Official Title  ICMJE Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Brief Summary In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
Detailed Description A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Cancer
Intervention  ICMJE Drug: S-1 plus oxaliplatin
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Other Names:
  • TS-1 plus oxaliplatin
  • Teysuno plus oxaliplatin
Study Arms  ICMJE No Intervention: S-1 plus oxaliplatin
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Intervention: Drug: S-1 plus oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≧18;
  • Histologically or cytologically confirmed gastrointestinal cancer;
  • ECOG ≦2;
  • Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
  • Life expectancy of at least three months;
  • Written informed consent to participate in the trial;

Exclusion Criteria:

  • History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
  • Inadequate hematopoietic function which is defined as below:

    • white blood cell (WBC) less than 3,500/mm^3
    • absolute neutrophil count (ANC) less than 1,500/mm^3
    • platelets less than 80,000/mm^3
  • Inadequate hepatic or renal function which is defined as below:

    • serum bilirubin greater than 1.5 times the upper limit of normal range
    • alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    • greater than 2.5 times the ULN if no demonstrable liver metastases or
    • greater than 5 times the ULN in the presence of liver metastases
    • blood creatinine level greater than 2 times ULN
  • Presence of peripheral neuropathy;
  • Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
  • Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
  • Psychiatric disorder or symptom that makes participation of the patient difficult;
  • Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
  • Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
  • Known DPD deficiency;
  • Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608646
Other Study ID Numbers  ICMJE TOTTG270105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: WENCHAO LIU, professor xijing hospital of the fourth military medical univercity
PRS Account Xijing Hospital
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP