A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
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.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of using MRI for intracavitary brachytherapy treatment planning.
No
United States: Institutional Review Board
UPCC 01809
NCT01016561
July 2009
July 2012
Name | Location |
---|---|
Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia, Pennsylvania 19104 |