Magnetic Resonance Imaging-Based Radiation Therapy and Cisplatin in Patients With Stage I, Stage II, Stage III, or Stage IV Cervical Cancer
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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 |
- Feasibility of using MRI for intracavitary brachytherapy treatment planning. [ Designated as safety issue: No ]
- 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 |
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| United States, Pennsylvania | |
| Abramson Cancer Center of the Unviersity of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
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 Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013