Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Официальное название

Feasibility Study of Novel Applications of Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Обзор

This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer undergoing chemoradiotherapy (chemoRT), including brachytherapy, as part of standard care. The primary goal is to assess feasibility. Other goals include determining whether gel placement can reduce radiation dose to nearby healthy organs (organs at risk, OAR) and improve delivery of the prescribed radiation dose to the tumor. In cervical cancer, the radiation dose to the tumor is often limited by the risk of exposing nearby sensitive organs, such as the rectum, bladder, and other pelvic structures. Vaginal packing techniques and specialized devices are used to protect these organs and ensure effective treatment. Gel spacers are inserted before radiation therapy to create space between the rectum and the cervix, reducing radiation exposure to healthy tissue. Already widely used in prostate cancer treatment in the U.S., gel spacers may also help improve tumor control and reduce treatment-related toxicity in cervical cancer.

Вмешательства

• Устройство Barrigel gel spacer
  Barrigel (Hyaluronic acid- based gel spacer) will be used to increase the distance between the cervix and the anterior rectal wall, with the intent to decrease the radiation dose delivered to the rectum.

Первичные конечные точки

• Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement [Срок оценки: Up to 3 months after completion of radiotherapy]
• Safety based on Patient Reported Outcome Report based on The Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment [Срок оценки: Up to 3 months after completion of radiotherapy]
• Safety based on Patient Reported Outcome Report based on Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to 3 months after completion of radiotherapy]
• Distance between uterus/cervix/proximal vagina and rectum [Срок оценки: Up to 7 weeks (at the end of radiotherapy)]
• Gel placement procedure time [Срок оценки: Up to 7 weeks (at the end of radiotherapy)]
• Difficulty of gel placement [Срок оценки: Up to 7 weeks (at the end of radiotherapy)]

Вторичные конечные точки (1)

• Implant geometry [Срок оценки: Up to 7 weeks (at the end of radiotherapy)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07292818 · LCCC2310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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