Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-30 @ 1:00 AM
Study NCT ID:
NCT04643366
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2020-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable 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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2033-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three-year disease free survival (DFS)', 'timeFrame': '3 years after end of treatment', 'description': 'The three-year disease free survival (DFS) defined as the number of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).'}], 'secondaryOutcomes': [{'measure': 'Pathologic complete response (pCR) rate', 'timeFrame': '3 Years after end of treatment', 'description': 'The number of patients that achieve pathologic complete response(pCR)(defined as negative surgical margins and no evidence of residual viable tumor) at time of total mesorectal excision (TME).'}, {'measure': 'Clinical complete response (cCR) following total neoadjuvant therapy (TNT) based on tumor response', 'timeFrame': '3 Years after end of treatment', 'description': 'Determine the cCR using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), in patients evaluable for response'}, {'measure': 'The number of Adverse events (AEs) per participant', 'timeFrame': '39 Months', 'description': 'The number of Adverse events (AEs) per participant characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v. 5.0)'}, {'measure': 'Progression (PFS) Rate', 'timeFrame': '3 Years after end of treatment', 'description': 'PFS defined as the time from initiation of chemotherapy until date of progression'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': '3 Years after end of treatment', 'description': 'OS defined as the time from initiation of chemotherapy until death by any cause.'}, {'measure': 'Number of patients who do not require an ostomy at time of surgery', 'timeFrame': '116 Days', 'description': 'After neoadjuvant therapy is complete patients will undergo assessment of disease status prior to determination of whether they will proceed to surgical resection or active surveillance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resectable', 'Rectal'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.', 'detailedDescription': 'This trial involves 4 cycles of systemic chemotherapy followed by short-course RT with concurrent 5-FU neoadjuvant chemoradiotherapy (CRT) and subsequent consolidation with 4 cycles of systemic chemotherapy prior to surgery or, for those who achieve cCR, the option of non-operative active surveillance.Three-year disease free survival (DFS) defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy\n* Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup:\n\n * Colonoscopy, unless patient presents with an obstructing lesion\n * Within 30 days prior to registration:\n* History/physical examination\n* Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis or whole-body PET-CT or MRI\n* Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging\n* ECOG Performance Status ≤1\n* Age ≥ 18 years\n* Adequate bone marrow function defined as follows:\n\n * Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3\n * Platelets ≥ 100,000 cells/mm3\n * Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dL is acceptable.)\n* Adequate liver and renal function defined as follows:\n\n * AST and alkaline phosphatase \\< 2.5 x upper limit of normal (ULN)\n * Bilirubin ≤ 2.5 ULN\n * Calculated creatinine clearance (CrCl) \\> 30 mL/min using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender\n* Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation\n* Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.\n* WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior RT that would result in overlap of RT fields with the planned study treatment\n* Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Serious (ie, ≥ grade 3) uncontrolled infection\n* Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Major surgery within 28 days of study enrollment (other than diverting colostomy)\n* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy\n* Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin\n* Known dipyrimidine dehydrogenase deficiency (DPD)\n* Any evidence of distant metastases (M1)\n* Pregnant or breast feeding\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements"}, 'identificationModule': {'nctId': 'NCT04643366', 'briefTitle': 'Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer', 'orgStudyIdInfo': {'id': 'MCC-18-14260'}, 'secondaryIdInfos': [{'id': 'HM20020384', 'type': 'OTHER', 'domain': 'Virginia Commonwealth University'}, {'id': 'NCI-2020-13796', 'type': 'OTHER', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent Chemotherapy/ Radiation Therapy', 'description': '5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) four 14-day cycles will be given before CRT starts. Pelvic Intensity-modulated radiation therapy (IMRT): 25 Gy in 5 fractions over 5 days + Continuous infusion 5-fluorouracil (5-FU) for 4 days (96 hours) followed by four 14-day cycles of (mFOLFOX6) to be given after CRT ends.', 'interventionNames': ['Drug: Chemotherapy', 'Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)', 'armGroupLabels': ['Concurrent Chemotherapy/ Radiation Therapy']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Pelvic Intensity-modulated radiation therapy (IMRT)', 'armGroupLabels': ['Concurrent Chemotherapy/ Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sue Moore, MSN, RN', 'role': 'CONTACT', 'email': 'smoore@vacancer.com', 'phone': '804-287-3000', 'phoneExt': '1261'}, {'name': 'Purvi Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Cancer Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Massey CTO GI Team, RN', 'role': 'CONTACT', 'email': 'masseygi@vcu.edu', 'phone': '804-628-6430'}, {'name': 'Khalid Matin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23970', 'city': 'South Hill', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Massey SIIT Team', 'role': 'CONTACT', 'email': 'masseysiit@vcu.edu'}], 'facility': 'VCU Community Memorial Healthcenter', 'geoPoint': {'lat': 36.72653, 'lon': -78.12889}}], 'centralContacts': [{'name': 'Massey IIT Research Operations, RN', 'role': 'CONTACT', 'email': 'masseyepd@vcu.edu', 'phone': '804-628-6430'}], 'overallOfficials': [{'name': 'Khalid Matin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massey Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}