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Poor accrual/enrollments
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracavitary balloon brachytherapy | Radiation |
| ||
| external beam radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiation |
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| intensity-modulated radiation therapy | Radiation |
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| radiation therapy treatment planning/simulation | Radiation |
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| 3-dimensional conformal radiation therapy | Radiation |
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| Cisplatin | Drug |
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| Pelvis Failure |
| Time to loco-regional recurrence |
| Progression-free Survival | Time to recurrence |
| Overall Survival | Time to death |
| COMPLETED |
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| NOT COMPLETED |
|
Despite all possible efforts to contact the PI/study team members, no data are available to be reported
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Age, Continuous | years | ||||||||||||||||||||||||||||||
| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
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| Region of Enrollment | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Completion of study |
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| Secondary | Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series. | 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 | Posted | 60 days post treatment |
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| Secondary | True Pelvis Failure | 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 | Posted | Time to local recurrence |
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| Secondary | Pelvis Failure | 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 | Posted | Time to loco-regional recurrence |
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| Secondary | Progression-free Survival | 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 | Posted | Time to recurrence |
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| Secondary | Overall Survival | Not enough patients were accrued to the study for analysis. | Posted | Time to death |
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The 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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lilie Lin, MD | University of Pennsylvania | 215-662-6515 | lin@xrt.upenn.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D020266 | Radiotherapy, Conformal |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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