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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01016561
First received: November 18, 2009
Last updated: February 25, 2013
Last verified: February 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events associated with brachytherapy delivered according to MRI-based treatment planning. [ Designated as safety issue: Yes ]
  • Frequency of grade 2 and higher gastrointestinal and genitourinary early event rates as compared to historical series. [ Designated as safety issue: Yes ]
  • True pelvis failure [ Designated as safety issue: No ]
  • Pelvis Failure [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: July 2012
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01016561     History of Changes
Other Study ID Numbers: UPCC 01809
Study First Received: November 18, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014