Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT06162650
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Neoadjuvant Therapy in 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': 'D060830', 'term': 'Consolidation Chemotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2030-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR) rate', 'timeFrame': 'The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy', 'description': 'The percentage of patients who achieve a complete response'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': 'The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy', 'description': 'The percentage of patients who receive the surgery of total neoadjuvant therapy and achieve R0 resection'}, {'measure': 'Response rate', 'timeFrame': 'The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy', 'description': 'The percentage of patients who achieve a complete response or partial response'}, {'measure': 'Loco-regional failure rate', 'timeFrame': 'The loco-regional failure will be assessed from the date of surgical resection until the first documented local recurrence, up to 84 months', 'description': 'The percentage of patients who develop local recurrence after surgery'}, {'measure': 'Rate of distant metastasis', 'timeFrame': 'The distant metastasis will be assessed from the date of beginning short-course RT until the first documented distant metastasis, up to 84 months', 'description': 'The percentage of patients who develop distant metastasis'}, {'measure': 'Safety profiles', 'timeFrame': 'The safety profile will be assessed from the beginning of the short-course RT to the end of last cycle of FOLFOX chemotherapy, up to 24 weeks', 'description': 'The occurrence and severity of adverse events which develop during the treatment of total neoadjuvant therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.', 'detailedDescription': 'This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the rectum;\n* Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);\n* Clinical stage II or III (T3/4 and/or N+; no distant metastasis);\n* No prior chemotherapy, radiotherapy or surgery for rectal cancer;\n* Age ≥20;\n* ECOG 0-1;\n* Adequate organ function, including followings:\n\nANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit;\n\n* Ability to understand and the willingness to sing a written informed consent.\n\nExclusion criteria\n\n* Recurrent rectal cancer;\n* Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;\n* Patients who have received prior pelvic radiotherapy;\n* Patients with active infection requiring intravenous antibiotic treatment;\n* Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;\n* Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study;\n* Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period;\n* Patients receiving other anticancer or experimental therapy;\n* Known DPD deficiency or hypersensitivity to oxaliplatin;\n* Any contraindications to MRI."}, 'identificationModule': {'nctId': 'NCT06162650', 'briefTitle': 'Total Neoadjuvant Therapy in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer', 'orgStudyIdInfo': {'id': 'B-BR-112-042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered.', 'interventionNames': ['Radiation: Short-course radiotherapy', 'Drug: mFOLFOX6']}], 'interventions': [{'name': 'Short-course radiotherapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'Short-course radiotherapy, 5×5 Gy.', 'armGroupLabels': ['Experimental arm']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'otherNames': ['Consolidation chemotherapy'], 'description': 'Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Min Yeh, MD', 'role': 'CONTACT', 'email': 'i5485111@gmail.com', 'phone': '886-6-2353535', 'phoneExt': '4289'}, {'name': 'Yu-Min Yeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Yu-Min Yeh, MD', 'role': 'CONTACT', 'email': 'i5485111@gmail.com', 'phone': '+886 353535', 'phoneExt': '6550'}], 'overallOfficials': [{'name': 'Yu-Min Yeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yu-Min Yeh', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}