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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix 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 with an inability to tolerate MR imaging 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br> <br> Radiation: external beam radiation therapy<br> <br> * Other names: EBRT;Radiation: intensity-modulated radiation therapy<br> <br> * Other names: IMRT;Radiation: radiation therapy treatment planning/simulation<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> * Other names: 3D-CRT, conformal radiation therapy;Drug: Cisplatin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning. | 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. | Completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series. |  | 60 days post treatment | 
| True Pelvis Failure |  | Time to local recurrence | 
| Pelvis Failure |  | Time to loco-regional recurrence | 
| Progression-free Survival |  | Time to recurrence | 
| Overall Survival |  | Time to death |