Cervical CancerPreserVNCT07855263
Vaginal Dose De-escalation During Brachytherapy for Cervical Cancer
A study testing radiation dose de-escalation in people with Cervical Cancer, run by Duke University.
Trial summary
The purpose of this study is to determine if it is possible to reduce the amount of radiation that the vagina receives during brachytherapy treatment, and to see how the change in radiation dose to the vagina impacts quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- radiation dose de-escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Feb 2032
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects aged 18 years or older
- Must be able to provide study specific informed consent prior to study entry
- Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the cervix
- Stage I-III according to the International Federation of Gynecology and Obstetrics (FIGO) 2018 edition (excepting FIGO IIA and IIIA, both indicating vaginal involvement)
- Supraclavicular nodal involvement is allowed (selected FIGO IVB) if there is no vaginal involvement
- Patients with oligometastatic disease (1-4 sites, addressable by surgery, SBRT or other definitive treatment) are allowed, if treated with curative doses to pelvic disease.
- ECOG performance status of 0-2
- The plan of care must include external beam radiation (with or without concurrent chemotherapy) followed by brachytherapy.
Who cannot join
- Disease involving the vagina
- Patients with Stage IVB disease according to the FIGO 2018 edition (with the exception of supraclavicular nodal disease, or oligometastatic disease as noted in inclusion)
- Any active malignancy within the previous 2 years that may alter the course of the current cancer treatment;
- Prior pelvic radiotherapy that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PreserV: A Feasibility Study of Vaginal Dose De-escalation During Brachytherapy in Patients With Cervical Cancer
The purpose of this study is to determine if it is possible to reduce the amount of radiation that the vagina receives during brachytherapy treatment, and to see how the change in radiation dose to the vagina impacts quality of life.
- Conditions
- Cervical Cancer
- Being tested
- radiation dose de-escalation
- Keywords
- brachytherapy, radiation therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation dose de-escalationRadiation
Participants will have brachytherapy delivered in a way that targets the cervical cancer while limiting the amount of radiation to the vagina and will complete quality of life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal dose de-escalation | Experimental | Not described Receives: Radiation: radiation dose de-escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of radiation dose de-escalation
Defined as >=66% of subjects (>=13/20) treated with the study definition of vaginal dose de-escalation
Measured: approximately 5 weeks
Secondary outcomes (3)
Safety of reducing vaginal radiation dose
defined as crude incidence of vaginal recurrence not greater than 15% (3/20)
Measured: 3 years
Late vaginal toxicity
measured descriptively based on physician reported grading and speculum measurements of vaginal length, caliber, and distensibility.
Measured: 3 years
Sexual health outcomes
measured using the Female Sexual Function Index (FSFI) questionnaire with a higher score indicating a better outcome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junzo Chino, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855263
- Sponsor's protocol ID
- Pro00121132
- Acronym
- PreserV
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreserV: A Feasibility Study of Vaginal Dose De-escalation During Brachytherapy in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT07855263
- Acronym / sponsor ID
- PreserV / Pro00121132
- Conditions
- Cervical Cancer
- Keywords
- brachytherapy, radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 2 Oct 2026 (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 purpose of this study is to determine if it is possible to reduce the amount of radiation that the vagina receives during brachytherapy treatment, and to see how the change in radiation dose to the vagina impacts quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal dose de-escalation | Experimental | Radiation: radiation dose de-escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult subjects aged 18 years or older
- Must be able to provide study specific informed consent prior to study entry
- Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the cervix
- Stage I-III according to the International Federation of Gynecology and Obstetrics (FIGO) 2018 edition (excepting FIGO IIA and IIIA, both indicating vaginal involvement)
- Supraclavicular nodal involvement is allowed (selected FIGO IVB) if there is no vaginal involvement
Key exclusion criteria (7 listed)
- Disease involving the vagina
- Patients with Stage IVB disease according to the FIGO 2018 edition (with the exception of supraclavicular nodal disease, or oligometastatic disease as noted in inclusion)
- Any active malignancy within the previous 2 years that may alter the course of the current cancer treatment;
- Prior pelvic radiotherapy that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
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 |
|---|---|---|
| radiation dose de-escalationParticipants will have brachytherapy delivered in a way that targets the cervical cancer while limiting the amount of radiation to the vagina and will complete quality of life questionnaires. | Radiation | Vaginal dose de-escalation |
Primary outcome
Feasibility of radiation dose de-escalation
Time frame: approximately 5 weeks
Defined as >=66% of subjects (>=13/20) treated with the study definition of vaginal dose de-escalation
3 secondary outcomes
Safety of reducing vaginal radiation dose
Time frame: 3 years
Late vaginal toxicity
Time frame: 3 years
Sexual health outcomes
Time frame: 3 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 2 Oct 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.
Junzo Chino, MD principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
A study testing radiation dose de-escalation in people with Cervical Cancer, run by Duke University.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Clinical Trials Office ((919) 668-3726, RadOnc-Clinical_Trials@dm.duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of radiation dose de-escalation (time frame: approximately 5 weeks). 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 2 Oct 2026.