Uterine Cervix CancerPhase 2NCT06331468
Hypofractionated Radiochemotherapy
A Phase 2 study testing Cisplatin, intensity modulated radiation therapy (IMRT) and high-dose-rate (HDR) brachytherapy in people with Uterine Cervix Cancer, run by Denise Fabian at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Uterine Cervix Cancer
- What is being tested?
- Cisplatin, intensity modulated radiation therapy (IMRT) and high-dose-rate (HDR) brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVA or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).
- 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
Who cannot join
- Presence of another concurrent active invasive malignancy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denise Fabian, MD contact
United States1 site, 1 recruiting
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40506
About this study
Official title: Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer
The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:
- 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?
Read more
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:
- 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.
- 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.
- Conditions
- Uterine Cervix Cancer
- Being tested
- Cisplatin, intensity modulated radiation therapy (IMRT), high-dose-rate (HDR) brachytherapy
- Keywords
- Uterine Neoplasm, Cisplatin
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol
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)Radiation
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) brachytherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy | Experimental | 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 Receives: Drug: Cisplatin; Radiation: intensity modulated radiation therapy (IMRT); Radiation: high-dose-rate (HDR) brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI assessed rate of complete response
MRI-assessed rates of complete response as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects
Measured: 1 month post treatment (day 60)
Secondary outcomes (5)
MRI assessed rate of complete response
The proportion of complete response will be assessed at 3-mos post-treatment completion, i.e., Day 120, as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects.
Measured: 3 months post treatment (day 120)
progression-free survival (PFS)
Progression-free survival (PFS) is calculated from the date of treatment start (week 1, day 1) to the date of initial disease progression or to the date of death or to 2-years post-treatment initiation, whichever occurs first.
Measured: up to 2 years
overall survival (OS)
Overall Survival is calculated from the date of treatment start until date of death or up to 2-years post-treatment initiation, whichever occurs first.
Measured: up to 2 years
Treatment Completion
reported as a proportion of subjects who complete entire prescribed course of the treatment based on the treatment compliance for Radiotherapy and for Cisplatin
Measured: up to 32 days
Treatment Tolerability
Assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start26 Jun 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denise Fabian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Denise Fabian, University of Kentucky
- Investigators
- Denise Fabian, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331468
- Sponsor's protocol ID
- MCC-23-GYN-10
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer
- ClinicalTrials.gov ID
- NCT06331468
- Acronym / sponsor ID
- MCC-23-GYN-10
- Conditions
- Uterine Cervix Cancer
- Keywords
- Uterine Neoplasm, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Denise FabianUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy | Experimental | Drug: Cisplatin, Radiation: intensity modulated radiation therapy (IMRT), Radiation: high-dose-rate (HDR) brachytherapyCisplatin 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVA or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).
- 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
Key exclusion criteria (8 listed)
- Presence of another concurrent active invasive malignancy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: PlatinolA 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. | Drug | Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy |
| 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. | Radiation | Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy |
| high-dose-rate (HDR) brachytherapyadministered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions. | Radiation | Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy |
Primary outcome
MRI assessed rate of complete response
Time frame: 1 month post treatment (day 60)
MRI-assessed rates of complete response as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects
5 secondary outcomes
MRI assessed rate of complete response
Time frame: 3 months post treatment (day 120)
progression-free survival (PFS)
Time frame: up to 2 years
overall survival (OS)
Time frame: up to 2 years
Treatment Completion
Time frame: up to 32 days
Treatment Tolerability
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denise Fabian, MD contact
Denise Fabian, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, intensity modulated radiation therapy (IMRT) and high-dose-rate (HDR) brachytherapy in people with Uterine Cervix Cancer, run by Denise Fabian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Taul, RN (859-323-2354, yvonne.taul@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI assessed rate of complete response (time frame: 1 month post treatment (day 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.