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Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211377
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Anyang Tumor Hospital

Tracking Information
First Submitted Date July 3, 2017
First Posted Date July 7, 2017
Last Update Posted Date July 11, 2017
Actual Study Start Date March 29, 2017
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2017)
disease free survival(DFS) [ Time Frame: up to 3 years ]
time from surgery to disease recurrence or death
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 5, 2017)
  • Overall survival (OS) [ Time Frame: up to 5 years ]
    time to death
  • Adverse events(AE) [ Time Frame: through study completion, up to 1 year ]
    Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Official Title Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Brief Summary This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population For this study patients had to be at least 18 years old with histologically or cytologically confirmed locally advanced esophagogastric junction cancer
Condition Esophagogastric Junction Cancer
Intervention Not Provided
Study Groups/Cohorts
  • neoadjuvant therapy group
    Preoperation chemotherapy treatment for patients up to four cycles
  • adjuvant therapy
    Postoperation chemotherapy treatment for patients up to six cycles
  • Perioperative therapy
    Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles
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 Recruiting
Estimated Enrollment
 (submitted: July 5, 2017)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 29, 2021
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytological proved locally advanced esophagogastric junction cancer
  • ECOG performance status ≦2
  • Stage IIa-IIIc
  • No distant metastasis (M0)
  • Sign in Informed Consent Form

Exclusion Criteria:

  • History of hypersensitivity to fluoropyrimidines, Tegafur,Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
  • Pregnancy or lactation women,
  • Inadequate hematopoietic function: WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
  • Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);

  • Symptomatic peripheral neuropathy
  • Receiving a concomitant treatment with other fluoropyrimidines
  • Fluoropyrimidines (DPD) congenital absence
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Li Baozhong 0372-2923314 drlibaozhong@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211377
Other Study ID Numbers TOTMSEJ1701
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anyang Tumor Hospital
Study Sponsor Anyang Tumor Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Anyang Tumor Hospital
Verification Date June 2017