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NCT07855263Not yet recruiting

Vaginal Dose De-escalation During Brachytherapy for Cervical Cancer

PreserV: A Feasibility Study of Vaginal Dose De-escalation During Brachytherapy in Patients With Cervical Cancer

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
28 Sept 2026
Start date
1 Dec 2026
Primary completion date
28 Feb 2029
Lead sponsor
Duke University
NCT number
NCT07855263

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Dec 2026 to the primary completion date, 28 Feb 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)
  • 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 known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Other

  • Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.