Cervical Cancer
Conditions
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.
Interventions
RADIATIONintracavitary balloon brachytherapy
RADIATIONexternal beam radiation therapy
RADIATIONintensity-modulated radiation therapy
RADIATION3-dimensional conformal radiation therapy
DRUGCisplatin
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Using MRI for Intracavitary Brachytherapy Treatment Planning. | Completion of study | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series. | 60 days post treatment |
| True Pelvis Failure | Time to local recurrence |
| Pelvis Failure | Time to loco-regional recurrence |
| Progression-free Survival | Time to recurrence |
| Overall Survival | Time to death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
intracavitary balloon brachytherapy
external beam radiation therapy
intensity-modulated radiation therapy
radiation therapy treatment planning/simulation
3-dimensional conformal radiation therapy
Cisplatin | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Completion of study
Population: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Secondary
Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
Time frame: 60 days post treatment
Population: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Secondary
Overall Survival
Time frame: Time to death
Population: Not enough patients were accrued to the study for analysis.
Secondary
Pelvis Failure
Time frame: Time to loco-regional recurrence
Population: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Secondary
Progression-free Survival
Time frame: Time to recurrence
Population: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported
Secondary
True Pelvis Failure
Time frame: Time to local recurrence
Population: he study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported