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

Not Applicable

Terminated

Conditions: Cervical Cancer

Interventions: 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

Registration Number: NCT01016561

Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	intracavitary balloon brachytherapy	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.
Arm I	radiation therapy treatment planning/simulation	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.
Arm I	3-dimensional conformal radiation therapy	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.
Arm I	external beam radiation therapy	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.
Arm I	intensity-modulated radiation therapy	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.
Arm I	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.	Completion of study	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.

Secondary Outcome Measures

Name	Time	Method
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
Progression-free Survival	Time to recurrence
Pelvis Failure	Time to loco-regional recurrence
Overall Survival	Time to death