Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-06-26
2028-07-01
Brief Summary
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* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?
* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?
* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?
* What is the proportion of patients who complete the treatment in prescribed timeframe?
* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?
To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:
* Complete history and physical exam, GOG performance status evaluation
* Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.
Treatment will be administered on an outpatient basis.
The main difference between the proposed regimen in the trial and standard of care is as follows:
1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.
2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.
This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.
IMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.
After active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).
Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.
Following the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy
Cisplatin two (2) one-time weekly intravenous infusions at 40 mg/m2 (70mg maximum)
IMRT once daily, four fractions per week for 2 weeks 4.56 Gy x 8 fractions
High dose rate Brachytherapy twice per week with a 2-day break in between sessions for a total of four brachytherapy treatments. The dose is 7 Gy x 4 fractions
Cisplatin
A total of two IV infusions of cisplatin will be administered on Day 1 and again on Day 8 +/- 1 day. Cisplatin starting dose is 40 mg/m2. Dose reduction is allowed (30 mg/m2) as needed for management of toxicities.
intensity modulated radiation therapy (IMRT)
given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.
high-dose-rate (HDR) brachytherapy
administered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions.
Interventions
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Cisplatin
A total of two IV infusions of cisplatin will be administered on Day 1 and again on Day 8 +/- 1 day. Cisplatin starting dose is 40 mg/m2. Dose reduction is allowed (30 mg/m2) as needed for management of toxicities.
intensity modulated radiation therapy (IMRT)
given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.
high-dose-rate (HDR) brachytherapy
administered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ and marrow function
* Gynecologic Oncology Group performance status of 0, 1, or 2
* Patient agrees to use two forms of birth control if they are of child-bearing potential
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Prior invasive malignancy diagnosed within the last three years, with the following two exceptions: \[a\] non-melanoma skin cancer and/or \[b\] prior in situ carcinoma of the cervix
* Receipt of prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician
* Currently receiving any other investigational agent(s) for the treatment of cancer
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin or other agents used in study
* Presence of uncontrolled intercurrent illness as determined by the treating physician
* pregnant or lactating
* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
18 Years
120 Years
FEMALE
No
Sponsors
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Denise Fabian
OTHER
Responsible Party
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Denise Fabian
Assistant Professor
Principal Investigators
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Denise Fabian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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Markey Cancer Center
Lexington, Kentucky, United States
Countries
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Central Contacts
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Denise Fabian, MD
Role: CONTACT
Other Identifiers
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MCC-23-GYN-10
Identifier Type: -
Identifier Source: org_study_id