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

Abramson Cancer Center at Penn Medicine

Status: Terminated

Conditions: Cervical Cancer

Treatments: Radiation: intensity-modulated radiation therapy; Radiation: radiation therapy treatment planning/simulation; Radiation: 3-dimensional conformal radiation therapy; Drug: Cisplatin; Radiation: external beam radiation therapy; Radiation: intracavitary balloon brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01016561

UPCC 01809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Radiation: radiation therapy treatment planning/simulation

Drug: Cisplatin

Radiation: external beam radiation therapy

Radiation: 3-dimensional conformal radiation therapy

Radiation: intracavitary balloon brachytherapy

Radiation: intensity-modulated radiation therapy