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Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

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: NCT02677597
Recruitment Status : Unknown
Verified February 2016 by Chang Jian Hua, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date February 9, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
PFS [ Time Frame: Since the date of random to disease progression or any cause of death,the average time is 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Official Title  ICMJE An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Brief Summary Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Cisplatin Combined With S-1
  • Drug: Cisplatin Combined With Paclitaxel
Study Arms  ICMJE
  • Experimental: Cisplatin Combined With S-1
    Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14
    Intervention: Drug: Cisplatin Combined With S-1
  • Experimental: Cisplatin Combined With Paclitaxel
    Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
    Intervention: Drug: Cisplatin Combined With Paclitaxel
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: February 8, 2016)
268
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven primary thoracic esophageal squamous cell carcinoma
  • Not suitable for surgery or radio or chemical therapy
  • Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
  • 18~70 years
  • PS:0-1
  • Life expectancy of ≥ 3 months
  • WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
  • TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
  • Scr≥60 mL/min
  • Normal electrocardiogram (ecg)
  • Can normal oral drugs
  • Signed written informed consent

Exclusion Criteria:

  • Breast-feeding or pregnant women, no effective contraception if risk of conception exists
  • Chronic diarrhea, enteritis, intestine obstruction which are not under control
  • Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
  • A second primary tumor (except skin basal cell carcinoma)
  • The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
  • With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
  • With bleeding tendency
  • Has inherited bleeding evidence of physical or blood coagulation disorder
  • With clear chemotherapy drug allergy
  • Other researchers believe that patients should not participate in this testing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 NCT02677597
Other Study ID Numbers  ICMJE CISPEC study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Chang Jian Hua, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date February 2016

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