Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-07 @ 8:26 AM
Study NCT ID:
NCT03200834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2017-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-01-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2017-03-25', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year survival', 'timeFrame': 'Up to 5 years post-operative', 'description': 'death from any cause'}], 'secondaryOutcomes': [{'measure': 'morbidity', 'timeFrame': 'within the first 30 days after surgery', 'description': 'postoperative complications'}, {'measure': 'mortality', 'timeFrame': 'within the first 30 days after surgery', 'description': 'death after surgery'}, {'measure': 'Disease free survival 5 years after initial surgery', 'timeFrame': 'Up to 5 years post-operative', 'description': 'local and distant metastasis during 5 years after operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right colon cancer', 'D3 dissection', 'complete mesocolic excision', 'Hemicolectomy'], 'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '38956698', 'type': 'DERIVED', 'citation': 'Balaban V, Mutyk M, Bondarenko N, Zolotukhin S, Sovpel O, Sovpel I, Zykov D, Rublevskiy I, Klochkov M, Prado AP, He M, Tsarkov P. Comparison of D2 vs D3 lymph node dissection for RIght COloN cancer (RICON): study protocol for an international multicenter open-label randomized controlled trial. Trials. 2024 Jul 2;25(1):438. doi: 10.1186/s13063-024-08269-5.'}]}, 'descriptionModule': {'briefSummary': 'Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Agreement of the patient to participate in trial\n2. Colon cancer (only adenocarcinoma )\n3. The tumor located between the cecum and the right 1/3 of transverse colon\n4. Tumors T3,Т4а,b N0-2 (II-III stages)\n5. Tolerance of chemotherapy\n6. ECOG 0-2\n\nExclusion Criteria:\n\n1. Patients with distant metastases\n2. Tumors T1-2 (I stage)\n3. Complications of tumor (perforation and full bowel obstruction)\n4. Previous radiotherapy or chemotherapy\n5. Synchronous or metachronous tumors\n6. Women during Pregnancy or breast feeding period'}, 'identificationModule': {'nctId': 'NCT03200834', 'briefTitle': 'Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)', 'organization': {'class': 'OTHER', 'fullName': 'G.V. Bondar Republican Cancer Center'}, 'officialTitle': 'Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'D2 lymph node dissection for right colon cancer', 'description': 'Hemicolectomy for right colon cancer with D2 lymph node dissection', 'interventionNames': ['Procedure: Right Hemicolectomy with D2 lymph node dissection']}, {'type': 'EXPERIMENTAL', 'label': 'D3 lymph node dissection for right colon cancer', 'description': 'Hemicolectomy for right colon cancer with D3 lymph node dissection', 'interventionNames': ['Procedure: Right Hemicolectomy with D3 lymph node dissection']}], 'interventions': [{'name': 'Right Hemicolectomy with D2 lymph node dissection', 'type': 'PROCEDURE', 'description': 'Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).', 'armGroupLabels': ['D2 lymph node dissection for right colon cancer']}, {'name': 'Right Hemicolectomy with D3 lymph node dissection', 'type': 'PROCEDURE', 'description': 'Remove right part of colon with lymph node dissection №201, №202, № 203, №211, №212 (if present), №213 (if present) №221,№222, №223 (for hepatic flexure and proximal part of transverse colon cancer)(Japanese classification).', 'armGroupLabels': ['D3 lymph node dissection for right colon cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'G.V. Bondar Republican Cancer Center', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}], 'overallOfficials': [{'name': 'Vladimir Balaban, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'M.Gorky Donetsk National Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G.V. Bondar Republican Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Donetsk National Medical University', 'class': 'OTHER'}, {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}