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Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
This study is currently recruiting participants.
Verified June 2017 by Anyang Tumor Hospital
Sponsor:
Anyang Tumor Hospital
Information provided by (Responsible Party):
Anyang Tumor Hospital
ClinicalTrials.gov Identifier:
NCT03211377
First received: July 3, 2017
Last updated: July 7, 2017
Last verified: June 2017
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Purpose
This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction
| Condition |
|---|
| Esophagogastric Junction Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma |
Further study details as provided by Anyang Tumor Hospital:
Primary Outcome Measures:
- disease free survival(DFS) [ Time Frame: up to 3 years ]time from surgery to disease recurrence or death
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 120 |
| Actual Study Start Date: | March 29, 2017 |
| Estimated Study Completion Date: | April 29, 2021 |
| Estimated Primary Completion Date: | March 29, 2019 (Final data collection date for primary outcome measure) |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211377
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211377
Contacts
| Contact: Li Baozhong | 0372-2923314 | drlibaozhong@163.com |
Locations
| 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
More Information
| Responsible Party: | Anyang Tumor Hospital |
| ClinicalTrials.gov Identifier: | NCT03211377 History of Changes |
| Other Study ID Numbers: |
TOTMSEJ1701 |
| Study First Received: | July 3, 2017 |
| Last Updated: | July 7, 2017 |
ClinicalTrials.gov processed this record on July 11, 2017