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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01444755 |
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Date of registration:
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29/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
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Scientific title:
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Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01444755 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Atilla Celik, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically proven adenocarcinoma of stomach
- T3 or T4
- N1 or N2
- M0
- No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal
dissemination or Krukenberg tumor.
- No involvement of the esophagus with > 2cm
- An age of 18-90 years
- A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group
(ECOG) performance status (0-2)
- No previous chemotherapy, radiotherapy for any malignancy.
- No previous surgery for gastric cancer
- No evidence obstructive or bleeding symptoms.
- Adequate renal and hepatic function
- Written informed consent
Exclusion Criteria:
- Synchronous or metachronous malignancy diagnosing within 5 year
- Pregnancy or lactation in female patients
- Any immunosuppressive condition (acquired or iatrogenic)
- Any infectious toxic or mental condition preventing neoadjuvant therapy
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Primary Outcome(s)
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Survival
[Time Frame: After 2 years from therapy]
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Secondary ID(s)
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HNEAH-01-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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