Vaginal Dose De-escalation During Brachytherapy for Cervical Cancer

NCT07855263 | Not Yet Recruiting

• 1 other identifier: Pro00121132
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cervical Cancer

Keywords

brachytherapy; radiation therapy

Outcome Measures

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

  approximately 5 weeks

Secondary Outcomes (3)

• Safety of reducing vaginal radiation dose

  3 years

• Late vaginal toxicity

  3 years

• Sexual health outcomes

  3 years

Study Arms (1)

Vaginal dose de-escalation

EXPERIMENTAL

Radiation: radiation dose de-escalation

Interventions

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.

Vaginal dose de-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Disease involving the vagina
• 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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Junzo Chino, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Office

CONTACT

(919) 668-3726; RadOnc-Clinical_Trials@dm.duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2032
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share