Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-02 @ 9:23 PM
Study NCT ID:
NCT02748551
Status:
UNKNOWN
Last Update Posted:
2016-12-13
First Post:
2016-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D061887', 'term': 'Conversion to Open Surgery'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-11', 'studyFirstSubmitDate': '2016-04-10', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Major" Surgical Morbidity', 'timeFrame': '21 days.', 'description': '"Major" Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.'}], 'secondaryOutcomes': [{'measure': '3-year progression-free survival', 'timeFrame': '36 months', 'description': 'In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures'}, {'measure': '3-year overall survival', 'timeFrame': '6, 12, 18, 24, 30 and 36 months', 'description': 'In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures'}, {'measure': '5-year overall survival rate', 'timeFrame': '6, 12, 18, 24, 30, 36, 48 and 60 months', 'description': 'In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 5 years compared with open procedures'}, {'measure': 'Surgical Mortality', 'timeFrame': '90 days', 'description': 'It is defined as the death within postoperative 90 days regardless of postoperative reason.'}, {'measure': 'Peri-operative blood loss', 'timeFrame': '1 day', 'description': "Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional 'open' group."}, {'measure': 'Postoperative recovery index', 'timeFrame': '10 days', 'description': 'Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course The amount of abdominal drainage and blood transfusion are also recorded'}, {'measure': 'Pain scores', 'timeFrame': 'up to 3 days after surgery', 'description': 'Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days'}, {'measure': 'Postoperative quality of life', 'timeFrame': '6, 12, 18, 24, 30 and 36 months', 'description': 'Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life'}, {'measure': 'long-term surgical morbidity', 'timeFrame': '21days - 36 months after surgery', 'description': 'Surgical morbidity is defined as the events which occurs with-in postoperative 21 days - 36 months after surgery. It is necessary to evaluate the complication, it is required to record complication name, date of on-set. Long complications are included: hernia, bleeding, bowel obstruction etc.'}, {'measure': 'Extent of lymph node dissection', 'timeFrame': '2 weeks', 'description': 'The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.'}]}, 'conditionsModule': {'keywords': ['Gastric cancer', 'locally advanced gastric cancer', 'laparoscopic surgery', 'laparoscopic procedure', 'comparison laparoscopic with open procedure', 'multicenter trials'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.\n\nStarting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG 0-1\n* ASA I-III\n* 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\n* 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\n* The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinically apparent distant metastasis\n* Free cancer cells\n* Bulky lymph node metastasis is detected by abdominal CT\n* Previous treatment with radiation therapy for any tumors.\n* Previous surgery for the present disease\n* Pregnancy\n* Psychiatric disease'}, 'identificationModule': {'nctId': 'NCT02748551', 'briefTitle': 'A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Moscow Clinical Scientific Center'}, 'officialTitle': 'Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'MKNC 01/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic surgery', 'description': 'Traditional open procedure for patient with locally advanced gastric cancer', 'interventionNames': ['Procedure: Open Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open surgery', 'description': 'Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer', 'interventionNames': ['Procedure: Laparoscopic procedures']}], 'interventions': [{'name': 'Laparoscopic procedures', 'type': 'PROCEDURE', 'description': 'Laparoscopic surgery', 'armGroupLabels': ['Open surgery']}, {'name': 'Open Surgery', 'type': 'PROCEDURE', 'description': 'Open surgery', 'armGroupLabels': ['Laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lipetsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Michail Lando, MD, PhD', 'role': 'CONTACT', 'email': 'abdlan@yandex.ru'}], 'facility': 'Lipetsk regional oncological center', 'geoPoint': {'lat': 52.5876, 'lon': 39.55151}}, {'zip': '111123', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Roman Izrailov, MD, PhD', 'role': 'CONTACT', 'email': 'izrailev@mail.ru', 'phone': '8 (495) 3042908'}, {'name': 'Boris Pomortsev, MD', 'role': 'CONTACT', 'email': 'b.pomortsev@mknc.ru', 'phone': '8(915)2107630'}, {'name': 'Michail Prostov', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moscow Clinical Scientific Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Pavel Kononets', 'role': 'CONTACT', 'email': 'p.kononets@onco62.ru'}], 'facility': 'Moscow Oncology Hospital 62', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Andrey Ryabov, MD, PhD', 'role': 'CONTACT', 'email': 'ryabovdoc@mail.ru'}], 'facility': 'P.Herzen Moscow Oncological Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vladimir Lyadov, MD, PhD', 'role': 'CONTACT', 'email': 'vlyadov@gmail.com'}], 'facility': 'Treatment and Rehabilitation Centre of Health Ministry of Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Victor Kashchenko, MD, PhD', 'role': 'CONTACT', 'email': 'med@fromru.com'}], 'facility': 'Federal Medical Biology Agence №122 the name of L.Soko', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Andrey Pavlenko, MD, PhD', 'role': 'CONTACT', 'email': 'andrewpavlenko@yandex.ru'}], 'facility': 'Leningradsky oncological center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexey Karachun, MD, PhD', 'role': 'CONTACT', 'email': 'dr.a.karachun@gmail.com'}], 'facility': 'N. Petrov National Research Institute of Oncology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Kiev', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Sergey Baydo, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Lisod clinic', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'centralContacts': [{'name': 'Igor Khathov, MD, PhD', 'role': 'CONTACT', 'email': 'ihatkov@gmail.com', 'phone': '8 (495) 3042908'}, {'name': 'Roman Izrailov, MD, PhD', 'role': 'CONTACT', 'email': 'izrailev@mail.ru', 'phone': '8 (495) 3042908'}], 'overallOfficials': [{'name': 'Michail Byachov, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Moscow Clinical Scientific Center'}, {'name': 'Roman Izrailov, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Moscow Clinical Scientific Center'}, {'name': 'Boris Pomortsev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Clinical Scientific Center'}, {'name': 'Pavel Kononets, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Oncological Hospital 62'}, {'name': 'Andrey Ryabov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P.Herzen Moscow Oncological Research Institute'}, {'name': 'Vladimir Lyadov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Treatment and Rehabilitation Centre of Health Ministry of Russia'}, {'name': 'Alexey Karachun, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'N. Petrov National Research Institute of Oncology'}, {'name': 'Victor Kashchenko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal Medical Biology Agence №122 the name of L.Sokolov'}, {'name': 'Andrey Pavlenko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leningradsky oncological center'}, {'name': 'Michail Lando, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lipetsk regional oncological center'}, {'name': 'Sergey Baydo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lisod clinic Kiev'}, {'name': 'Igor Khatkov, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Moscow Clinical Scientific Center'}, {'name': 'Michail Prostov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Clinical Scientific Center'}, {'name': 'Kirill Schostka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leningradsky oncological center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Clinical Scientific Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}