Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT06812728
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete clinical response rate', 'timeFrame': '6 months', 'description': 'an absence of clinical, endoscopic or imaging evidence of a rectal tumor during the restaging of a patient with locally advanced rectal cancer after neoadjuvant therapy.'}], 'secondaryOutcomes': [{'measure': 'Toxicity of chemotherapy', 'timeFrame': '6 months', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v 5'}, {'measure': 'complete pathological response rectal cancer', 'timeFrame': '6 months', 'description': 'the absence of malignant cells on the specimen of rectal resection in patients who were previously treated with neoadjuvant CRT.'}, {'measure': 'disease-free survival', 'timeFrame': '3 years', 'description': 'Disease-free survival (DFS) will be defined as the time from randomization to recurrence of tumor or death'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant', 'mFOLFIRINOX', 'TNT', 'Watch and wait approach', 'Complete clinical response', 'Sphincter sparing'], 'conditions': ['Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'A phase II clinical trial compared standard TNT (mFolfox6 and CRT) with preoperative chemoradiotherapy (CRT) with neoadjuvant chemotherapy (CT) containing mFolfirinox in patients with locally advanced rectal cancer.', 'detailedDescription': 'This open-label randomized, two-arm phase II trial compared the standard total neoadjuvant approach (TNT) with neoadjuvant CT with mFolfirinox and preoperative CRT in patients with locally advanced rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven rectal adenocarcinoma.\n2. Stages cT3 with risk of local recurrence, cT4, or N positive, M0 and for which a multidisciplinary meeting recommend TNT.\n3. Resectable tumor, or considered as potentially resectable after CRT.\n4. No distant metastases.\n5. Patient eligible for surgery\n6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/1.\n7. No heart failure or coronary heart disease symptoms (even controlled).\n8. No peripheral neuropathy \\> grade 1.\n9. No prior radiotherapy of the pelvis for any reason and no previous CT\n10. No major comorbidity that may preclude the delivery of treatment\n11. Adequate contraception in fertile patients.\n12. Adequate hematologic function.\n\n13 Adequate hepatic function.\n\n14\\. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Metastatic disease\n2. Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1\n3. Medical history of chronic diarrhea or inflammatory disease of the colon or rectum\n4. Medical history of angina pectoris or myocardial infarction\n5. Other concomitant cancer.\n6. Pregnant or breast-feeding woman.\n7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT06812728', 'briefTitle': 'Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy Versus Standard Total Neoadjuvant Approach for Locally Advanced Rectal Cancer Patients: a Randomized Controlled Phase 2 Trial.', 'orgStudyIdInfo': {'id': 'R2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (mFolfox6)', 'description': 'Chemotherapy (mFolfox6) then radiochemotherapy', 'interventionNames': ['Drug: mFolfox6']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (mFOLFIRINOX)', 'description': 'Chemotherapy (mFOLFIRINOX) then radiochemotherapy', 'interventionNames': ['Drug: mFOLFIRINOX']}], 'interventions': [{'name': 'mFOLFIRINOX', 'type': 'DRUG', 'description': 'Neoadjuvant chemotherapy', 'armGroupLabels': ['Arm B (mFOLFIRINOX)']}, {'name': 'mFolfox6', 'type': 'DRUG', 'description': 'Neoadjuvant chemotherapy', 'armGroupLabels': ['Arm A (mFolfox6)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'faculty of medicine', 'role': 'CONTACT', 'email': 'medcine@menofia.edu.eg', 'phone': '0482330325', 'phoneExt': '+20'}, {'role': 'CONTACT', 'phone': '0482224819', 'phoneExt': '+20'}], 'facility': 'Medicine', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'E Morkos', 'role': 'CONTACT', 'email': 'yoyonagy7@gmail.com', 'phone': '00201061323285'}], 'overallOfficials': [{'name': 'Yostena Mekhail, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'yostena nagy kamel mekhail', 'investigatorAffiliation': 'Menoufia University'}}}}