Hyaluronic acid gel spacer to protect nearby organs during cervical cancer radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1 pilot at UNC testing whether a hyaluronic acid-based gel (Barrigel) can be placed to create space between the cervix and surrounding pelvic organs before chemoradiotherapy that includes brachytherapy. The primary goal is to determine feasibility of gel placement and integration into standard treatment workflows. Secondary aims include measuring whether the spacer reduces radiation dose to organs at risk (rectum, bladder, other pelvic structures) and whether it improves delivery of the prescribed tumor dose. Eligible adults planned for chemoradiotherapy with brachytherapy are enrolled, with exclusions for rectal invasion, inflammatory bowel disease, pregnancy, active infection, or known allergy to hyaluronic acid products.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subject is willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at time of consent.
* Eastern Cooperative Oncology Group Performance Status of 0-2 or Karnofsky Performance Scale score of 50-100.
* Histological or cytological evidence of cervical cancer. Only patients with cervical cancer who are planned for chemoradiotherapy with brachytherapy, except for individuals with known rectal invasion.

Exclusion Criteria:

* Active infection requiring systemic therapy.
* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study).
* Known allergy to hyaluronic acid-based products.
* Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

Where it's running

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Shivani Sud, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Melissa Knutsen
• Email: Melissa_Knutsen@med.unc.edu
• Phone: 919-966-4432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Late radiation side effects after postoperative IMRT and brachytherapy for cervical and endometrial cancer

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• Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV

  This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.

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• Outcomes for Oligometastatic and Oligorecurrent Cervical Cancer

  This registry will see if adding local treatments such as radiation or surgery to standard systemic therapy helps people with oligo‑metastatic or oligo‑recurrent cervical cancer live longer or avoid progression.

  Recruiting Tata Memorial Hospital · Mumbai, Maharashtra · NCT07400809

• Short-course (hypofractionated) versus standard radiotherapy with cisplatin and brachytherapy for locally advanced cervical cancer in Uganda

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  Recruiting Phase 2 Uganda Cancer Institute · Kampala, Kampala · NCT07276360

• Minimally invasive simple hysterectomy for low-risk cervical cancer

  This study is testing if a less invasive surgery called a simple hysterectomy is safe for women with low-risk early-stage cervical cancer.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT06416748

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.