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


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of using MRI for intracavitary brachytherapy treatment planning.

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UPCC 01809

NCT ID:

NCT01016561

Start Date:

July 2009

Completion Date:

July 2012

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms

Name

Location

Abramson Cancer Center of the Unviersity of PennsylvaniaPhiladelphia, Pennsylvania  19104