Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT03941366
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2019-05-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients in the trial receive the intervention and are followed prospectively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission', 'timeFrame': '18 months', 'description': 'Percent of patients who achieve complete remission'}, {'measure': 'Partial remission', 'timeFrame': '18 months', 'description': 'Percent of patients who achieve partial remission'}, {'measure': 'Disease progression', 'timeFrame': '18 months', 'description': 'Percent of patients with disease progression'}, {'measure': 'Local resection', 'timeFrame': '18 months', 'description': 'Percent of patients who require local resection only'}], 'secondaryOutcomes': [{'measure': 'Patient quality of life', 'timeFrame': '18 months', 'description': 'Quality of life score on questionnaire'}, {'measure': 'Patient health status', 'timeFrame': '18 months', 'description': 'Patient self-reported health status'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.', 'detailedDescription': 'The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission.\n\nThis is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life.\n\nAll procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Diagnosis of rectal invasive adenocarcinoma\n3. Tumor in the low or mid rectum (up to 11 cm from the anal verge)\n4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.\n\n1\\. Clinical staging will be estimated based on the combination of the following assessments:\n\n1. Physical examination by the primary surgeon\n2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis\n3. Pelvic MRI and endoscopic ultrasound\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Do not complete informed consent\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03941366', 'briefTitle': 'Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders', 'orgStudyIdInfo': {'id': '866142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Neoadjuvant Chemotherapy and Follow-up Surgery', 'description': 'All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.', 'interventionNames': ['Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery']}], 'interventions': [{'name': 'Standard of care chemotherapy with the change for avoidance of extensive surgery', 'type': 'PROCEDURE', 'description': 'All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.', 'armGroupLabels': ['Neoadjuvant Chemotherapy and Follow-up Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa C. Miller, BA', 'role': 'CONTACT', 'email': 'lisa.miller@ascension.org', 'phone': '313-343-3166'}, {'name': 'Amr Aref, MD', 'role': 'CONTACT', 'email': 'amr.aref@ascension.org', 'phone': '313-343-3166'}], 'facility': 'Ascension St. John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'Lisa C Miller, BA', 'role': 'CONTACT', 'email': 'lisa.miller4@ascension.org', 'phone': '313-343-3166'}, {'name': 'Susan M Szpunar, PhD', 'role': 'CONTACT', 'email': 'susan.szpunar@ascension.org', 'phone': '313-343-7838'}], 'overallOfficials': [{'name': 'Amr Aref, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascension SME'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Radiation Oncology', 'investigatorFullName': 'Amr Aref', 'investigatorAffiliation': 'Henry Ford Health System'}}}}