Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT01016561|
Recruitment Status : Unknown
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : November 19, 2009
Last Update Posted : December 15, 2015
|Condition or disease||Intervention/treatment|
|Cervical Cancer||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|
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:
I. To evaluate the feasibility of using MRI based treatment planning for intracavitary brachytherapy treatment planning.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer|
|Study Start Date :||July 2009|
|Primary Completion Date :||July 2012|
Experimental: 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.
Radiation: intracavitary balloon brachytherapy
Radiation: external beam radiation therapy
Other Name: EBRTRadiation: intensity-modulated radiation therapy
Other Name: IMRTRadiation: radiation therapy treatment planning/simulation Radiation: 3-dimensional conformal radiation therapy
Other Name: 3D-CRT, conformal radiation therapyDrug: Cisplatin
- Feasibility of using MRI for intracavitary brachytherapy treatment planning.
- Adverse events associated with brachytherapy delivered according to MRI-based treatment planning.
- Frequency of grade 2 and higher gastrointestinal and genitourinary early event rates as compared to historical series.
- True pelvis failure
- Pelvis Failure
- Progression-free survival
- Overall survival
- Toxicity as assessed by NCI CTCAE version 3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016561
|United States, Pennsylvania|
|Abramson Cancer Center of the Unviersity of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|