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

NCT05690906 | Unknown Phase 2 DMC

• 1 other identifier: RN-CT-001-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical Cancer; Hydrogel Spacer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy

  during procedure

• The implantation success rate of hydrogel.

  during procedure

• The stability of ReSpace™ Hydrogel

  during procedure

• QLQ-C30

  during procedure

• QLQ-CX24

  during procedure

Study Arms (2)

ReSpace™ & gauze packing

EXPERIMENTAL

All of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy

Device: ReSpace™; Device: gauze packing

gauze packing

ACTIVE COMPARATOR

All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy

Device: gauze packing

Interventions

ReSpace™ DEVICE

The experimental group subjects will be injected with ReSpace™ hydrogel.

ReSpace™ & gauze packing

gauze packing DEVICE

The subjects of both groups will be given gauze packing

ReSpace™ & gauze packing; gauze packing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 22484226 BACKGROUND

• 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.

  PMID: 30237814 BACKGROUND

• 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.

  PMID: 31034570 BACKGROUND

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

Central Study Contacts

Fuquan Zhang, doctor

CONTACT

+86 13311360431; zhangfuquan3@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: July 12, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)