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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016561
• Other study ID #: UPCC 01809
• Status: Terminated
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 2016

Study information

• Verified date: May 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• intracavitary balloon brachytherapy

• external beam radiation therapy

• intensity-modulated radiation therapy

• radiation therapy treatment planning/simulation

• 3-dimensional conformal radiation therapy

Drug:
• Cisplatin

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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