An interventional study of intracavitary balloon brachytherapy and external beam radiation therapy in Cervical Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Radiation: intensity-modulated radiation therapy · Radiation: radiation therapy treatment planning/simulation · Radiation: 3-dimensional conformal radiation therapy · Drug: Cisplatin
Also known as: EBRT
Also known as: IMRT
Also known as: 3D-CRT, conformal radiation therapy
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
Frequency of Grade 2 and Higher Gastrointestinal and Genitourinary Early Event Rates as Compared to Historical Series.
Time frame: 60 days post treatment
True Pelvis Failure
Time frame: Time to local recurrence
Pelvis Failure
Time frame: Time to loco-regional recurrence
Progression-free Survival
Time frame: Time to recurrence
Overall Survival
Time frame: Time to death
| Milestone | Arm I |
|---|---|
| Started | 0 |
| Completed | 0 |
| Not completed | 0 |
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.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | — | — |
Despite all possible efforts to contact the PI/study team members, no data are available to be reported
| Age, Categorical | Arm I |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous(years) | Arm I |
|---|
| Sex: Female, Male | Arm I |
|---|---|
| Female | — |
| Male | — |
| Ethnicity (NIH/OMB) | Arm I |
|---|---|
| Hispanic or Latino | — |
| Not Hispanic or Latino | — |
| Unknown or Not Reported | — |
| Race (NIH/OMB) | Arm I |
|---|---|
| American Indian or Alaska Native | — |
| Asian | — |
| Native Hawaiian or Other Pacific Islander | — |
| Black or African American | — |
| White | — |
| More than one race | — |
| Unknown or Not Reported | — |
| Region of Enrollment(participants) | Arm I |
|---|
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abramson Cancer Center at Penn Medicine