Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT06167967
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 990}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival at 3 years', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival at 5 years', 'timeFrame': '5 years'}, {'measure': 'ctDNA clearance rate in ctDNA-positive patients treated with adjuvant chemotherapy', 'timeFrame': '6 months'}, {'measure': 'The proportion of patients in the low-risk cohort who did not receive adjuvant chemotherapy', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'ctDNA methylation', 'adjuvant chemotherapy'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are:\n\n1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients.\n2. Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients.\n\n325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years old ≤ age \\< 75 years old.\n2. Stage III (T1-4, N1-2, M0) colorectal cancer patients.\n3. Patients who can undergo R0 resection.\n4. ECOG score 0 \\~ 2.\n5. Expected survival ≥ 6 months.\n6. No history of other malignant tumors.\n7. Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients who have received neoadjuvant chemotherapy.\n2. Known high clinical risk of adjuvant chemotherapy.\n3. Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age).\n4. Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance).\n5. Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc.\n6. There are any other circumstances that the researcher deems unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT06167967', 'acronym': 'cmPAT', 'briefTitle': 'Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer: a Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SRRS-cmPAT'}, 'secondaryIdInfos': [{'id': 'SRRS2023-0704', 'type': 'REGISTRY', 'domain': 'Ethics Committee of Sir Run Run Shaw Hospital, School of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ctDNA-guided group', 'description': 'ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months; ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months; ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months; ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.', 'interventionNames': ['Diagnostic Test: ctDNA methylation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard treatment group', 'description': 'The standard treatment group in the high-risk cohort were treated with XELOX regimen for 6 months, and in the low-risk cohort were treated with XELOX regimen for 3 months.', 'interventionNames': ['Diagnostic Test: standard treatment']}], 'interventions': [{'name': 'ctDNA methylation', 'type': 'DIAGNOSTIC_TEST', 'description': 'A blood-based circulating tumor DNA methylation assay that uses 6 different methylation markers, SEPT9 region1, SEPT9 region2, BCAT1, IKZF1, BCAN and VAV3.', 'armGroupLabels': ['ctDNA-guided group']}, {'name': 'standard treatment', 'type': 'DIAGNOSTIC_TEST', 'description': 'This group was treated according to standard procedure', 'armGroupLabels': ['standard treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310016', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhangfa Song, Dr', 'role': 'CONTACT', 'email': 'songzhangfa@zju.edu.cn', 'phone': '+86 13867421652'}, {'name': 'Zhangfa Song, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sir Run Run Shao hospital'}], 'centralContacts': [{'name': 'Bingjun Bai, Dr', 'role': 'CONTACT', 'email': 'echobai@zju.edu.cn', 'phone': '+8613858816897'}], 'overallOfficials': [{'name': 'Zhangfa Song, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice director', 'investigatorFullName': 'Zhangfa Song', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}