Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04923620
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2021-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological response rate', 'timeFrame': 'two weeks after surgery', 'description': 'Tumor Regression Grade 0-1'}], 'secondaryOutcomes': [{'measure': 'Pathological complete response rate', 'timeFrame': 'two weeks after surgery', 'description': 'Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)'}, {'measure': '2-year local control rate', 'timeFrame': '2 years after enrollment', 'description': 'Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.'}, {'measure': '2-year metastasis-free rate 2-year distant metastasis free rate', 'timeFrame': '2 years after enrollment', 'description': 'Refers to the probability of no distant metastasis within 2 years'}, {'measure': 'Overall survival', 'timeFrame': '2 years after enrollment', 'description': 'Refers to the time from the start of treatment to death due to any cause.'}, {'measure': 'disease-free survival', 'timeFrame': '2 years after enrollment', 'description': 'Refers to the time from the start of treatment to recurrence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoadjuvant Treatment', 'Rectal Cancer', 'Cetuximab', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 to 75 years with locally advanced rectal cancer, regardless of gender, ethnicity and regional distribution, were involved in this study. Patients were required to be in good health and have sufficient organ function and bone marrow function.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A biopsy proven histological diagnosis of rectal adenocarcinoma；\n2. An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;\n3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;\n4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;\n5. Age between 18-75 years;\n6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;\n7. Has sufficient organ function:\n\n * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L\n * Liver function: ALT and AST \\< 2.5 × ULN;\n * Renal function: serum creatinine \\< 1.5 ULN;\n8. Willing to participate and informed consent signed；\n\nExclusion Criteria:\n\n1. Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High;\n2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;\n3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;\n4. Female patients who are pregnant or breastfeeding;\n5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;\n6. Patients with active infection;\n7. Poor overall health status, ECOG ≥ 2;\n8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;\n9. Known hypersensitivity reactions to any investigational drugs;'}, 'identificationModule': {'nctId': 'NCT04923620', 'briefTitle': 'Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Minimally Invasive Surgery Center'}, 'officialTitle': 'Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'MISC-Cet-FOLFOX-SCRT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cetuximab+mFOLFOX6', 'type': 'DRUG', 'description': 'cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles'}, {'name': 'short-course radiotherapy', 'type': 'RADIATION', 'description': '25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenghao Cai', 'role': 'CONTACT', 'email': 'c3z2h1@alumni.sjtu.edu.cn', 'phone': '+862164458887'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhenghao Cai, MD', 'role': 'CONTACT', 'email': 'c3z2h1@alumni.sjtu.edu.cn', 'phone': '+862164458887'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Minimally Invasive Surgery Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cai Zhenghao', 'investigatorAffiliation': 'Shanghai Minimally Invasive Surgery Center'}}}}