Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04747951
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Neoadjuvant Therapy in Rectal Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D060830', 'term': 'Consolidation Chemotherapy'}, {'id': 'C519688', 'term': 'XELOX'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of complete responses', 'timeFrame': '3-6 months', 'description': 'The rate of pathological or clinical complete responses'}], 'secondaryOutcomes': [{'measure': 'Rate of R0-resections', 'timeFrame': 'immediately after surgery', 'description': 'Rate of R0-resections'}, {'measure': 'Rate of compliance with radiotherapy and chemotherapy', 'timeFrame': '6-8 months', 'description': 'Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)'}, {'measure': 'rate of intraoperative and postoperative complications', 'timeFrame': '0-30 days after surgery', 'description': 'Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'total neoadjuvant therapy', 'colorectal disease'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22362002', 'type': 'BACKGROUND', 'citation': 'Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.'}, {'pmid': '22434243', 'type': 'BACKGROUND', 'citation': 'Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21.'}, {'pmid': '16246976', 'type': 'BACKGROUND', 'citation': 'Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.', 'detailedDescription': 'In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have signed an approved informed consent form for the stud;\n* Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);\n\nExclusion Criteria:\n\n* rectal cancer recurrence;\n* Primary-multiple tumours of other localizations;\n* pelvis radiotherapy in anamnesis;\n* pregnancy, breastfeeding;\n* distant metastasis;\n* ECOG score 3-4'}, 'identificationModule': {'nctId': 'NCT04747951', 'briefTitle': 'Total Neoadjuvant Therapy in Rectal Cancer Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'Total Neoadjuvant Therapy in Rectal Cancer Treatment', 'orgStudyIdInfo': {'id': '127872'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'total neoadjuvant therapy', 'description': 'Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Procedure: TME', 'Drug: consolidation chemotherapy', 'Drug: adjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard therapy', 'description': 'Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Procedure: TME', 'Drug: adjuvant chemotherapy']}], 'interventions': [{'name': 'Concurrent Chemoradiotherapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Radiotherapy'], 'description': '50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.\n\nConcurrent chemotherapy:\n\nCapecitabine 1650 mg/m2/d', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy']}, {'name': 'TME', 'type': 'PROCEDURE', 'description': 'Total mesorectal excision', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy']}, {'name': 'consolidation chemotherapy', 'type': 'DRUG', 'otherNames': ['XELOX', 'CAPOX'], 'description': 'Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course', 'armGroupLabels': ['total neoadjuvant therapy']}, {'name': 'adjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['mFOLFOX'], 'description': 'Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles', 'armGroupLabels': ['standard therapy', 'total neoadjuvant therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123453', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey Sychev', 'role': 'CONTACT', 'email': 'dr.sychev.si@gmail.com', 'phone': '+79097845436', 'phoneExt': '+79097845436'}], 'facility': 'State Scientific Centre of Coloproctology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Sergey Sychev, Dr.Med.Sc', 'role': 'CONTACT', 'email': 'dr.sychev.si@gmail.com', 'phone': '+7 9097845436'}], 'overallOfficials': [{'name': 'Evgeny Rybakov, Dr.Med.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Surgical department of oncoproctology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Surgical department of oncoproctology', 'investigatorFullName': 'Rybakov Evgeny, MD', 'investigatorAffiliation': 'State Scientific Centre of Coloproctology, Russian Federation'}}}}