Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT04664504
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2020-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
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': 'D060830', 'term': 'Consolidation Chemotherapy'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2020-12-06', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '1 year', 'description': 'R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy'}], 'secondaryOutcomes': [{'measure': '3y OS', 'timeFrame': '3 years', 'description': '3-year overall survival'}, {'measure': '3yDMFS', 'timeFrame': '3 years', 'description': '3-year distant metastatic free survival'}, {'measure': '3yLRRFS', 'timeFrame': '3 years', 'description': '3-year locoregional recurrence-free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Cancer', 'Neoadjuvant Chemoradiotherapy', 'Recurrence Risk'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk', 'detailedDescription': 'For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Rectal adenocarcinoma confirmed by histopathology\n2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)\n3. The age is 18-75 years old, no gender limit\n\n3\\) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1\n\nExclusion Criteria:\n\n1. History of other malignant tumors;\n2. They were allergic to 5-FU, platinum, etc;\n3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;\n4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;\n5. History of gastrointestinal fistula, perforation or severe ulcer;\n6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II 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': 'NCT04664504', 'briefTitle': 'A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk', 'orgStudyIdInfo': {'id': '3332019055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group CRT', 'description': 'concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)', 'interventionNames': ['Combination Product: Concurrent Chemoradiotherapy Radiotherapy', 'Drug: Adjuvant chemotherapy', 'Procedure: TME']}, {'type': 'EXPERIMENTAL', 'label': 'Group SCRT', 'description': 'Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)', 'interventionNames': ['Radiation: Short-course Radiotherapy', 'Drug: Consolidation chemotherapy', 'Procedure: TME']}, {'type': 'EXPERIMENTAL', 'label': 'Group es-SCRT', 'description': 'Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)', 'interventionNames': ['Radiation: Local dose increase of Short-course Radiotherapy', 'Drug: Consolidation chemotherapy', 'Procedure: TME']}], 'interventions': [{'name': 'Concurrent Chemoradiotherapy Radiotherapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['CRT'], 'description': '50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.', 'armGroupLabels': ['Group CRT']}, {'name': 'Short-course Radiotherapy', 'type': 'RADIATION', 'otherNames': ['SCRT'], 'description': '25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.', 'armGroupLabels': ['Group SCRT']}, {'name': 'Local dose increase of Short-course Radiotherapy', 'type': 'RADIATION', 'otherNames': ['es-SCRT'], 'description': '25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.', 'armGroupLabels': ['Group es-SCRT']}, {'name': 'Consolidation chemotherapy', 'type': 'DRUG', 'otherNames': ['XEOLX*4 courses'], '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 4 cycles. 4 courses\\*3 weeks per course.', 'armGroupLabels': ['Group SCRT', 'Group es-SCRT']}, {'name': 'Adjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['XEOLX*6 courses'], 'description': '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. 6 courses\\*3 weeks per course', 'armGroupLabels': ['Group CRT']}, {'name': 'TME', 'type': 'PROCEDURE', 'description': 'Total mesorectal excision', 'armGroupLabels': ['Group CRT', 'Group SCRT', 'Group es-SCRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Tang, MD', 'role': 'CONTACT', 'email': 'tangyuan82@162.com', 'phone': '0086-15011304945'}], '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}}], 'centralContacts': [{'name': 'Yuan Tang, M.D.', 'role': 'CONTACT', 'email': 'tangyuan82@162.com', 'phone': '+8615011304945'}], 'overallOfficials': [{'name': 'Yuan Tang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Jin, M.D.', 'class': 'UNKNOWN'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Radiotherapy Department', 'investigatorFullName': 'Jing Jin, M.D.', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}