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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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9 January 2017 |
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Main ID: |
NCT02748551 |
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Date of registration:
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10/04/2016 |
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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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A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
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Scientific title:
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Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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800 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02748551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Ukraine
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Contacts
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Name:
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Vladimir Lyadov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Treatment and Rehabilitation Centre of Health Ministry of Russia |
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Name:
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Michail Lando, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lipetsk regional oncological center |
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Name:
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Boris Pomortsev, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Clinical Scientific Center |
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Name:
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Igor Khatkov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Clinical Scientific Center |
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Name:
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Victor Kashchenko, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal Medical Biology Agence ?122 the name of L.Sokolov |
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Name:
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Roman Izrailov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Clinical Scientific Center |
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Name:
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Igor Khathov, MD, PhD |
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Address:
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Telephone:
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8 (495) 3042908 |
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Email:
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ihatkov@gmail.com |
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Affiliation:
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Name:
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Andrey Pavlenko, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Leningradsky oncological center |
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Name:
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Michail Byachov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Clinical Scientific Center |
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Name:
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Andrey Ryabov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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P.Herzen Moscow Oncological Research Institute |
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Name:
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Kirill Schostka, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Leningradsky oncological center |
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Name:
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Sergey Baydo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lisod clinic Kiev |
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Name:
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Michail Prostov |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Clinical Scientific Center |
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Name:
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Pavel Kononets, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moscow Oncological Hospital 62 |
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Name:
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Alexey Karachun, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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N. Petrov National Research Institute of Oncology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ECOG 0-1
- ASA I-III
- Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0
at preoperative evaluation according to the American Joint Committee on Cancer (AJCC)
Cancer Staging Manual Seventh Edition
- Preoperative examination with no distant metastasis, no significantly enlarged lymph
nodes around abdominal main artery, and tumor not a direct violation of the pancreas,
spleen and other surrounding organs
- The gastric tumors are located in the stomach, are macroscopically resectable by
subtotal or total gastrectomy with D2 lymph node dissection.
- Written informed consent
Exclusion Criteria:
- Clinically apparent distant metastasis
- Free cancer cells
- Bulky lymph node metastasis is detected by abdominal CT
- Previous treatment with radiation therapy for any tumors.
- Previous surgery for the present disease
- Pregnancy
- Psychiatric disease
Age minimum:
18 Years
Age maximum:
82 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Intervention(s)
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Procedure: Open Surgery
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Procedure: Laparoscopic procedures
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Primary Outcome(s)
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"Major" Surgical Morbidity
[Time Frame: 21 days.]
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Secondary Outcome(s)
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3-year progression-free survival
[Time Frame: 36 months]
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Surgical Mortality
[Time Frame: 90 days]
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long-term surgical morbidity
[Time Frame: 21days - 36 months after surgery]
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Pain scores
[Time Frame: up to 3 days after surgery]
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Peri-operative blood loss
[Time Frame: 1 day]
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Postoperative quality of life
[Time Frame: 6, 12, 18, 24, 30 and 36 months]
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3-year overall survival
[Time Frame: 6, 12, 18, 24, 30 and 36 months]
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5-year overall survival rate
[Time Frame: 6, 12, 18, 24, 30, 36, 48 and 60 months]
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Extent of lymph node dissection
[Time Frame: 2 weeks]
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Postoperative recovery index
[Time Frame: 10 days]
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Secondary ID(s)
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MKNC 01/2016
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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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