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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016561
First Posted: November 19, 2009
Last Update Posted: December 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention
Cervical Cancer 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of MR Imaging Based Intracavitary Brachytherapy for Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Feasibility of using MRI for intracavitary brachytherapy treatment planning.

Secondary Outcome Measures:
  • Adverse events associated with brachytherapy delivered according to MRI-based treatment planning.
  • Frequency of grade 2 and higher gastrointestinal and genitourinary early event rates as compared to historical series.
  • True pelvis failure
  • Pelvis Failure
  • Progression-free survival
  • Overall survival
  • Toxicity as assessed by NCI CTCAE version 3.0

Enrollment: 20
Study Start Date: July 2009
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Radiation: intracavitary balloon brachytherapy Radiation: external beam radiation therapy
Other Name: EBRT
Radiation: intensity-modulated radiation therapy
Other Name: IMRT
Radiation: radiation therapy treatment planning/simulation Radiation: 3-dimensional conformal radiation therapy
Other Name: 3D-CRT, conformal radiation therapy
Drug: Cisplatin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016561


Locations
United States, Pennsylvania
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01016561     History of Changes
Other Study ID Numbers: UPCC 01809
First Submitted: November 18, 2009
First Posted: November 19, 2009
Last Update Posted: December 15, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents