Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 5:07 AM
Study NCT ID:
NCT04139967
Status:
TERMINATED
Last Update Posted:
2023-07-14
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Short Course Radiation Therapy for Elderly Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'recruitment rates were too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '5 years', 'description': 'Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.'}, {'measure': 'Number of participants who experience a grade 2 adverse event', 'timeFrame': 'week 5', 'description': 'CTCAE V4.0 will be used to determine the grade 2 AE.'}], 'secondaryOutcomes': [{'measure': 'Number of participants who received surgery for their cancer', 'timeFrame': '5 years'}, {'measure': 'Number of participant who experience metastatic disease', 'timeFrame': '5 years', 'description': 'MRI or endoscopy will be used to track metastasis to other parts of the body'}, {'measure': 'Change in Mean quality of life', 'timeFrame': 'baseline to 24 months', 'description': 'Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.'}, {'measure': 'Change in Mean functional status', 'timeFrame': 'baseline to 24 months', 'description': 'Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.'}, {'measure': 'Number of participants with improved symptoms', 'timeFrame': '5 years', 'description': 'Symptoms will be documented by the treating physician at each clinical visit for 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer, Rectal']}, 'descriptionModule': {'briefSummary': 'This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 years or older at time of diagnosis\n* No restrictions on gender or ethnicity\n* Ability and willingness to make follow up appointments\n* Pathologic diagnosis of rectal cancer\n* Presentation could be symptomatic or asymptomatic\n* T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis\n* Peri-rectal node positive allowed\n* Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery\n* Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology\n* Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule\n\nExclusion Criteria:\n\n* Age under 70 years of age\n* Ability and desire to receive definitive surgical intervention\n* Ability and desire to receive concurrent chemoradiation therapy'}, 'identificationModule': {'nctId': 'NCT04139967', 'briefTitle': 'Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer', 'orgStudyIdInfo': {'id': '4297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly rectal cancer patients', 'interventionNames': ['Radiation: Short course radiation therapy']}], 'interventions': [{'name': 'Short course radiation therapy', 'type': 'RADIATION', 'description': '25 Gray in 5 fractions over 5-7 days', 'armGroupLabels': ['Elderly rectal cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center at University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Haoming (Carl) Qiu', 'investigatorAffiliation': 'University of Rochester'}}}}