Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer

A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Study to Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer

This phase II clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative D2cc dose for rectum during brachytherapy will be recorded and compared.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Device: ReSpace™; Device: gauze packing

Detailed Description

This phase II prospective, multicenter, randomized, parallel-controlled, superiority clinical study will select more than three hospitals with national clinical trial institution qualifications as clinical trial centers, plan to recruit 100 subjects, 50 in experimental group and 50 in control. The patients in expermental group will receive brachytherapy after the hydrogel injection while patients in control group will receive brachytherapy without hydrogel. The aim of the study was to evaluate whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum, and to assess its safety.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fuquan Zhang, doctor; Phone Number: +86 13311360431; Email: zhangfuquan3@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Junfang Yan, doctor; Phone Number: +86 18611286276; Email: yanjunfang@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.

  • Karnofsky score ≥ 70.
  • Subjects aged ≥ 18 years and ≤ 75 years.
  • Subjects must be able to cooperate in completing the entire study.
  • The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
  • No contraindications to CT scanning.
  • Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form

Exclusion Criteria:

• •Subjects who have received prior pelvic radiotherapy.

  • Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
  • Subjects with other primary malignancies
  • Subjects with contraindications to radiotherapy, as determined by the investigators
  • Subjects with injection site infections.
  • Subjects who are allergic to the ingredients of the device.
  • Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
  • Persons with severe mental illness, cognitive impairment and thinking disorders.
  • Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
  • Pregnant or lactating women or those who plan to get pregnant within the last six months
  • Subjects who cannot be followed up as prescribed by the doctor
  • Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReSpace™ & gauze packing; All of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy	Device: ReSpace™; The experimental group subjects will be injected with ReSpace™ hydrogel.; Device: gauze packing; The subjects of both groups will be given gauze packing
Active Comparator: gauze packing; All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy	Device: gauze packing; The subjects of both groups will be given gauze packing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative D2cc dose for rectum during brachytherapy	The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects and be compared between the groups.	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy	The mean of the cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy will be calculated for subjects and be compared between the groups.	during procedure
The implantation success rate of hydrogel.	A successful injection means the hydrogel is placed between the cervical and rectum	during procedure
The stability of ReSpace™ Hydrogel	The maximum distance of cervical to rectum of different time during the procedure will be compared to assess the stability of hydrogel.	during procedure
Evaluation of device performance of hydrogel spacer	The ease of use of the test device will be evaluated by the investigator on the day of Operation. The evaluation items are as follows#; Whether the device is easy to assemble.; Whether the process of positioning the needle is smooth and whether it is easy to position the needle.; Whether the device is easy to inject and whether the injection process is smooth	during procedure
QLQ-C30	The EORTC QLQ-C30 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome.	during procedure
QLQ-CX24	The EORTC QLQ-CX24 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome.	during procedure

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• de Freitas AC, Gurgel AP, Chagas BS, Coimbra EC, do Amaral CM. Susceptibility to cervical cancer: an overview. Gynecol Oncol. 2012 Aug;126(2):304-11. doi: 10.1016/j.ygyno.2012.03.047. Epub 2012 Apr 4.
• Peach MS, Moore J, Giles W, Trainor J, Long T, Moon N, Hylton JE, Showalter TN, Libby B. Development and preclinical testing of a novel biodegradable hydrogel vaginal packing technology for gynecologic high-dose-rate brachytherapy. J Contemp Brachytherapy. 2018 Aug;10(4):306-314. doi: 10.5114/jcb.2018.77952. Epub 2018 Aug 31.
• Kashihara T, Murakami N, Tselis N, Kobayashi K, Tsuchida K, Shima S, Masui K, Yoshida K, Takahashi K, Inaba K, Umezawa R, Igaki H, Ito Y, Kato T, Uno T, Itami J. Hyaluronate gel injection for rectum dose reduction in gynecologic high-dose-rate brachytherapy: initial Japanese experience. J Radiat Res. 2019 Jul 1;60(4):501-508. doi: 10.1093/jrr/rrz016.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cervical Cancer; Hydrogel Spacer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: RN-CT-001-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No