Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-31 @ 10:04 PM
Study NCT ID:
NCT01016561
Status:
TERMINATED
Last Update Posted:
2021-05-05
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lin@xrt.upenn.edu', 'phone': '215-662-6515', 'title': 'Lilie Lin, MD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'The study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': 'Completion of study', 'description': 'Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}, {'type': 'SECONDARY', 'title': 'Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': '60 days post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}, {'type': 'SECONDARY', 'title': 'True Pelvis Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': 'Time to local recurrence', 'reportingStatus': 'POSTED', 'populationDescription': 'he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}, {'type': 'SECONDARY', 'title': 'Pelvis Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': 'Time to loco-regional recurrence', 'reportingStatus': 'POSTED', 'populationDescription': 'he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': 'Time to recurrence', 'reportingStatus': 'POSTED', 'populationDescription': 'he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'timeFrame': 'Time to death', 'reportingStatus': 'POSTED', 'populationDescription': 'Not enough patients were accrued to the study for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Despite all possible efforts to contact the PI/study team, no data are available to be reported', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Despite all possible efforts to contact the PI/study team, no data are available to be reported', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nintracavitary balloon brachytherapy\n\nexternal beam radiation therapy\n\nintensity-modulated radiation therapy\n\nradiation therapy treatment planning/simulation\n\n3-dimensional conformal radiation therapy\n\nCisplatin'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'Despite all possible efforts to contact the PI/study team members, no data are available to be reported'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Poor accrual/enrollments', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2009-11-18', 'resultsFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2009-11-18', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2009-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.', 'timeFrame': 'Completion of study', 'description': 'Feasibility will be defined if no greater than 10% of patients experience one of the following events: a) patient is unable to tolerate 50% of MRI-based brachytherapy treatments and b) patient experiences any grade 4 acute ("early") non-hematologic toxicity attributed to brachytherapy. Acute toxicity occurs within 60 days of therapy.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.', 'timeFrame': '60 days post treatment'}, {'measure': 'True Pelvis Failure', 'timeFrame': 'Time to local recurrence'}, {'measure': 'Pelvis Failure', 'timeFrame': 'Time to loco-regional recurrence'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Time to recurrence'}, {'measure': 'Overall Survival', 'timeFrame': 'Time to death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Rationale: Computer systems that allow doctors to create a 3 dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy.', 'detailedDescription': 'PURPOSE: This clinical trial is studying magnetic resonance imaging-based radiation therapy and cisplatin in treating patients with stage I, stage II, stage III, or stage IV cervical cancer.Detailed DescriptionPRIMARY OBJECTIVES:\n\nI. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.\n\nII. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.\n\nIII. To evaluate local, regional, and distant recurrence rates. IV. To evaluate disease-free and overall survival rates. OUTLINE: Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.\n\nAfter completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix\n* Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer\n* Claustrophobic subjects must agree to be sedated during MRI procedures\n* ECOG performance status of 0-2\n\nExclusion Criteria:\n\n* Subjects with an inability to tolerate MR imaging\n* Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy\n* Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants\n* Women of childbearing potential who have a positive result on screening serum pregnancy test'}, 'identificationModule': {'nctId': 'NCT01016561', 'briefTitle': 'Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer', 'orgStudyIdInfo': {'id': 'UPCC 01809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.', 'interventionNames': ['Radiation: intracavitary balloon brachytherapy', 'Radiation: external beam radiation therapy', 'Radiation: intensity-modulated radiation therapy', 'Radiation: radiation therapy treatment planning/simulation', 'Radiation: 3-dimensional conformal radiation therapy', 'Drug: Cisplatin']}], 'interventions': [{'name': 'intracavitary balloon brachytherapy', 'type': 'RADIATION', 'armGroupLabels': ['Arm I']}, {'name': 'external beam radiation therapy', 'type': 'RADIATION', 'otherNames': ['EBRT'], 'armGroupLabels': ['Arm I']}, {'name': 'intensity-modulated radiation therapy', 'type': 'RADIATION', 'otherNames': ['IMRT'], 'armGroupLabels': ['Arm I']}, {'name': 'radiation therapy treatment planning/simulation', 'type': 'RADIATION', 'armGroupLabels': ['Arm I']}, {'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'otherNames': ['3D-CRT, conformal radiation therapy'], 'armGroupLabels': ['Arm I']}, {'name': 'Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the Unviersity of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}