Clinical trial NCT01016561: Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
Official title: A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning.
timeFrame: Completion of study
Secondary outcomes:
measure: Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
timeFrame: 60 days post treatment
measure: True Pelvis Failure
timeFrame: Time to local recurrence
measure: Pelvis Failure
timeFrame: Time to loco-regional recurrence
measure: Progression-free Survival
timeFrame: Time to recurrence
measure: Overall Survival
timeFrame: Time to death
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the Unviersity of Pennsylvania
state: Pennsylvania
Study officials:
References: