Health TrialsbyHealthPanel

Vaginal Dose De-escalation During Brachytherapy for Cervical Cancer

ConditionCervical Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • radiation dose de-escalation

    Radiation

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Vaginal dose de-escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of radiation dose de-escalation

Defined as \>=66% of subjects (\>=13/20) treated with the study definition of vaginal dose de-escalation

Time frame
approximately 5 weeks

Secondary outcomes

1

Safety of reducing vaginal radiation dose

defined as crude incidence of vaginal recurrence not greater than 15% (3/20)

Time frame
3 years
2

Late vaginal toxicity

measured descriptively based on physician reported grading and speculum measurements of vaginal length, caliber, and distensibility.

Time frame
3 years
3

Sexual health outcomes

measured using the Female Sexual Function Index (FSFI) questionnaire with a higher score indicating a better outcome

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: