Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-28 @ 9:27 PM
Study NCT ID:
NCT04543695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
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': 'C519688', 'term': 'XELOX'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of tumor down-staging', 'timeFrame': '6-8 months', 'description': 'Tumor down-staging is considered as Stage yp0-II after surgery, and watch-and-wait strategy after complete clinical response (cCR) was allowed.'}], 'secondaryOutcomes': [{'measure': 'Rate of compliance with TNT', 'timeFrame': '6-8 months', 'description': 'Rate of compliance with TNT'}, {'measure': '3y OS', 'timeFrame': '3years', 'description': '3-year overall survival (3yOS)'}, {'measure': '3y DFS', 'timeFrame': '3years', 'description': '3-year disease free survival (3yDFS)'}, {'measure': '3y DMFS', 'timeFrame': '3 years', 'description': '3-year distant metastatic free survival(3yDMFS)'}, {'measure': '3y LRRFS', 'timeFrame': '3 years', 'description': '3-year locoregional recurrence-free survival(3yLRRFS)'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': '3 years', 'description': 'EORTC QLQ-C30 to assess the quality of life'}, {'measure': 'EORTC QLQ-CR29', 'timeFrame': '3 years', 'description': 'EORTC QLQ-CR29 to assess the quality of life'}, {'measure': 'Wexner continence grading scale', 'timeFrame': '3 years', 'description': 'Wexner continence grading scale'}, {'measure': 'CTCAE 4.0', 'timeFrame': '6-8months', 'description': 'Severe acute adverse reaction rate（≥III degree）'}, {'measure': 'Incidence of surgical complications', 'timeFrame': '6-8 months', 'description': 'Incidence of surgical complications'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Radiotherapy', 'High Risk', 'Total Neoadjuvant Therapy'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer', 'detailedDescription': 'Recommended treatment of patients with locally advanced rectal cancer (LARC) includes preoperative chemoradiation (CRT), total mesorectal excision (TME) and postoperative adjuvant chemotherapy (ACT). However, treatments fail to show an improved therapeutic effect on high-risk patients now. Total neoadjuvant therapy (TNT) is a new try for rectal cancer treatment,and this trial aims to identify and select the more promising TNT sequence.\n\nThis trail is a multicenter, randomized, phase II trial . Eligible patients age from 18 to 75 years with histologically confirmed rectal adenocarcinoma. MRI is mandatory, and patients of stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. Patients are randomly assigned to 3 groups, group 1: concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group);or group 2: concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group);Or group 3: induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).The primary end point is the rate of tumor down-staging, which is defined as stage yp0-II after surgery,and watch-and-wait strategy after complete clinical response (cCR) was allowed. Secondary end points include acute toxicity, compliance with TNT, surgical complications, 3-year overall survival (3yOS),3-year disease free survival (3yDFS),3-year distant metastatic free survival(3yDMFS),3-year locoregional recurrence-free survival(3yLRRFS) and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. 18-75 years old, regardless of gender\n2. Histologically confirmed rectal adenocarcinoma;\n3. Up to 12 cm above the anal verge on the basis of rigid rectoscopy.\n4. MRI of the rectum is acceptable;\n5. Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.\n6. ECOG score 0-1 or KPS score ≥80.\n\nExclusion Criteria:\n\n1. History of malignant tumor in other parts;\n2. Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;\n3. During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;\n4. History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;\n5. History of digestive tract fistula, perforation or severe ulcer;\n6. Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or congestive heart failure; Unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.'}, 'identificationModule': {'nctId': 'NCT04543695', 'briefTitle': 'A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'NCC201809007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'adjuvant chemotherapy group', 'description': 'concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Drug: XELOX', 'Drug: mFOLFOX', 'Procedure: TME']}, {'type': 'EXPERIMENTAL', 'label': 'consolidation chemotherapy group (CNCT group)', 'description': 'concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group)', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Drug: XELOX', 'Drug: mFOLFOX', 'Procedure: TME']}, {'type': 'EXPERIMENTAL', 'label': 'induction chemotherapy group (INCT group)', 'description': 'induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy', 'Drug: XELOX', 'Drug: mFOLFOX', 'Procedure: TME']}], 'interventions': [{'name': 'Concurrent Chemoradiotherapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Radiotherapy:\n\n50Gy 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': ['adjuvant chemotherapy group', 'consolidation chemotherapy group (CNCT group)', 'induction chemotherapy group (INCT group)']}, {'name': 'XELOX', 'type': 'DRUG', 'otherNames': ['CAOPX'], '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 6 cycles.\n\n6 courses，3 weeks per course', 'armGroupLabels': ['adjuvant chemotherapy group', 'consolidation chemotherapy group (CNCT group)', 'induction chemotherapy group (INCT group)']}, {'name': 'mFOLFOX', 'type': 'DRUG', '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 9 cycles.', 'armGroupLabels': ['adjuvant chemotherapy group', 'consolidation chemotherapy group (CNCT group)', 'induction chemotherapy group (INCT group)']}, {'name': 'TME', 'type': 'PROCEDURE', 'description': 'Total mesorectal excision', 'armGroupLabels': ['adjuvant chemotherapy group', 'consolidation chemotherapy group (CNCT group)', 'induction chemotherapy group (INCT group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jing Jin, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Jilin Provincial Tumor Hospital', 'class': 'OTHER'}, {'name': 'Cancer Hospital of Guizhou Province', 'class': 'OTHER'}, {'name': 'Xijing Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor，Radiotherapy Department', 'investigatorFullName': 'JIN JING', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}