NCT01016561

Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer

A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2016-12-01
• First posted: 2009-11-19
• Last updated: 2021-05-05
• Results posted: 2021-05-05

Locations

1 site across 1 country: United States