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RecruitingNCT05690906Updated Jul 6, 2023

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

A Phase 2 interventional study of ReSpace™ and gauze packing in Uterine Cervical Neoplasms, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-06.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Jul 2022, registered Jan 2023).
  • Started Jul 2022; still recruiting 4 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Uterine Cervical Neoplasms

Keywords

  • Cervical Cancer
  • Hydrogel Spacer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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™ · Device: 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

Interventions

  • DeviceReSpace™

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

  • Devicegauze packing

    The subjects of both groups will be given gauze packing

06

What researchers measure

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.

    Time frame: during procedure

Secondary outcomes

  1. 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.

    Time frame: during procedure

  2. The implantation success rate of hydrogel.

    A successful injection means the hydrogel is placed between the cervical and rectum

    Time frame: during procedure

  3. 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.

    Time frame: during procedure

  4. 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.

    Time frame: during procedure

  5. 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.

    Time frame: during procedure

  6. 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# 1. Whether the device is easy to assemble. 2. Whether the process of positioning the needle is smooth and whether it is easy to position the needle. 3. Whether the device is easy to inject and whether the injection process is smooth

    Time frame: during procedure

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing, China
    Recruiting
08

References and documents

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. PubMed 22484226 ↗
  • 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. PubMed 30237814 ↗
  • 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. PubMed 31034570 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05690906
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Jan 19, 2023
Start date
Jul 12, 2022
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Jul 6, 2023

Study contacts

Fuquan Zhang, doctor
Contact
zhangfuquan3@126.com
+86 13311360431

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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