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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

Brief Summary:
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction

Condition or disease
Esophagogastric Junction Cancer

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : April 29, 2021

Group/Cohort
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



Primary Outcome Measures :
  1. disease free survival(DFS) [ Time Frame: up to 3 years ]
    time from surgery to disease recurrence or death


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 5 years ]
    time to death

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211377


Contacts
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Contact: Li Baozhong 0372-2923314 drlibaozhong@163.com

Locations
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China, Henan
Department of science and education Recruiting
Anyang, Henan, China
Contact: Wang, MD    0372-2923314    ayzlyykjk@163.com   
Sponsors and Collaborators
Anyang Tumor Hospital
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Responsible Party: Anyang Tumor Hospital
ClinicalTrials.gov Identifier: NCT03211377    
Other Study ID Numbers: TOTMSEJ1701
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms