Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
NCT ID: NCT01016561
Last Updated: 2021-05-05
Study Results
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View full resultsBasic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2009-07-31
2016-12-31
Brief Summary
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Detailed Description
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I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of early toxicities, specifically genitourinary and gastrointestinal.
II. To evaluate the incidence of late toxicities, specifically genitourinary and gastrointestinal.
III. 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.
After completion of study treatment, patients are followed at 6 weeks, every 4 months for 2 years, and then every 6 months for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
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.
intracavitary balloon brachytherapy
external beam radiation therapy
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
3-dimensional conformal radiation therapy
Cisplatin
Interventions
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intracavitary balloon brachytherapy
external beam radiation therapy
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
3-dimensional conformal radiation therapy
Cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer
* Claustrophobic subjects must agree to be sedated during MRI procedures
* ECOG performance status of 0-2
Exclusion Criteria
* Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy
* 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
* Women of childbearing potential who have a positive result on screening serum pregnancy test
18 Years
FEMALE
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC 01809
Identifier Type: -
Identifier Source: org_study_id
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