Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT01148056
Status:
TERMINATED
Last Update Posted:
2017-02-15
First Post:
2010-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkempner@partners.org', 'phone': '508.533.4132', 'title': 'Maria Kempner', 'organization': 'Mass General Hospital Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was closed early due to poor accrual. Analyses not completed.'}}, 'adverseEventsModule': {'timeFrame': '30 Days', 'description': 'Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'elevated bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'low phosphorus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'edema', 'notes': 'lower extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pilonidal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bowel Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early due to slow accrual. Analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Pelvic Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine the pelvic control rate of patients after short course radiation therapy and surgery.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed early due to poor accrual. Analyses not completed.'}, {'type': 'SECONDARY', 'title': 'Surgical Complication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine the surgical complication rate in patients who received preoperative radiation therapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed early due to poor accrual. Analyses not completed.'}, {'type': 'SECONDARY', 'title': 'Tissue Microarray', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine changes in the tumor induced by radiation as assessed by tissue microarray.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed early due to poor accrual. Analyses not completed.'}, {'type': 'SECONDARY', 'title': 'Quantity of Circulating Tumor Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed early due to poor accrual. Analyses not completed.'}, {'type': 'SECONDARY', 'title': 'Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'timeFrame': '2 years', 'description': 'To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was closed early due to poor accrual. Analyses not completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Short Course IMRT', 'description': 'Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after\n\nIntensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study was closed to enrollment due to slow accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2010-06-18', 'resultsFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2010-06-18', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-22', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel Quality of Life', 'timeFrame': '2 years', 'description': 'To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.'}], 'secondaryOutcomes': [{'measure': 'Pelvic Control Rate', 'timeFrame': '2 years', 'description': 'To determine the pelvic control rate of patients after short course radiation therapy and surgery.'}, {'measure': 'Surgical Complication Rate', 'timeFrame': '2 years', 'description': 'To determine the surgical complication rate in patients who received preoperative radiation therapy.'}, {'measure': 'Tissue Microarray', 'timeFrame': '2 years', 'description': 'To determine changes in the tumor induced by radiation as assessed by tissue microarray.'}, {'measure': 'Quantity of Circulating Tumor Cells', 'timeFrame': '2 years', 'description': 'To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.'}, {'measure': 'Accuracy', 'timeFrame': '2 years', 'description': 'To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IMRT', 'radiation therapy'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study will investigate short course radiation therapy using IMRT as an alternative to standard chemo radiation because prior studies have shown that this method of treatment will potentially reduce some fo the side effects of standard treatment, improve quality of life, and help to control the growth of rectal cancer cells. IMRT is a type of radiation that uses computer-generated images to match radiation to the size and shape of the tumor. Since the intensity of each radiation beam can be controlled, the radiation dose can wrap around normal tissue which allows the study doctor to deliver a higher dose of radiation to the tumor with less damage to nearby healthy tissue. The purpose of this research study is to see what impact this treatment will have on quality of life, as well as to see if there are any late side effects that come about after the participant has completed the treatment.', 'detailedDescription': '* Radiation treatment to the rectum will be given once a day, for 5 days. Each radiation treatment will take about 20-30 minutes.\n* The following procedures will be performed on day 1 of radiation treatment: physical examination, blood tests and quality of life questionnaire.\n* During radiation treatment a physical examination will be performed once during the 5 days of radiation treatment. A Quality of Life Questionnaire will be administered on the last day of radiation treatment.\n* Surgery will be performed within 3-14 days after the last day of radiation treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the rectum\n* T3 or N+ disease by MRI or endoscopic ultrasound. Metastatic disease is permitted, except for known brain metastases, as long as local treatment with RT and surgery is recommended.\n* Prior chemotherapy is permitted. For patients who have previously received bevacizumab, the last dose must be greater than 4 weeks prior to initiation of radiation therapy.\n* 18 years of age or older\n* Life expectancy of greater than 3 months\n* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1 or 2\n* Normal organ and marrow function as outlined in the protocol\n* Women of child-bearing potential and men must agree to use of adequate contraception prior to study entry and for the duration of study participation\n\nExclusion Criteria:\n\n* Pelvic radiotherapy prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Participants may not be receiving any other investigational agents. Patients may not be receiving any other treatment for their rectal cancer during study participation\n* Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* History of known radiation sensitivity syndrome\n* History of inflammatory bowel disease\n* Active scleroderma or CREST syndrome\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT01148056', 'briefTitle': 'Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Phase II Study of Neoadjuvant Short Course Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer: An Analysis of Quality of Life and Biomarkers of Response', 'orgStudyIdInfo': {'id': '09-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short course IMRT', 'description': 'Patients will receive short course IMRT (Intensity Modulated Radiation Therapy) prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after', 'interventionNames': ['Radiation: Intensity Modulated Radiation Therapy']}], 'interventions': [{'name': 'Intensity Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT'], 'description': 'Radiation therapy once a day for 5 days', 'armGroupLabels': ['Short course IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Theodore S. Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hosptial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Theodore Sunki Hong', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}