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Uterine Cervical NeoplasmsPhase 2NCT05690906

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

A Phase 2 study testing ReSpace™ and gauze packing in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
ReSpace™ and gauze packing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
12 Jul 2022to Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • •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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Fuquan Zhang, doctor contact

+86 13311360431

zhangfuquan3@126.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

    Junfang Yan, doctor, +86 18611286276, yanjunfang@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Being tested
ReSpace™, gauze packing
Keywords
Cervical Cancer, Hydrogel Spacer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReSpace™Device

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

  • gauze packingDevice

    The subjects of both groups will be given gauze packing

Study groups in NCT05690906
Study groupRoleWhat they receive
ReSpace™ & gauze packingExperimentalAll of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy
Receives: Device: ReSpace™; Device: gauze packing
gauze packingActive comparatorAll of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy
Receives: Device: gauze packing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during procedure

Secondary outcomes (6)

  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.

    Measured: during procedure

  2. The implantation success rate of hydrogel.

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start12 Jul 2022
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05690906
Sponsor's protocol ID
RN-CT-001-2
Status last verified
Jul 2023
First submitted
10 Jan 2023
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

  • Wang Y, Zhang X, Wang F, Chen W, Cao X, Ou Y, Zhang Z, Ke G, Liu Z, Wang T, Xie P, Guo Q, Zhang W, Zhai J, Li G, Pan Z, Hou S, Zhang Z, Wang Y, Yan J, Qiu J, Zhang F. Dosimetric and Clinical Effects of Polyethylene Glycol Gel in Radical Concurrent Chemoradiation Therapy for Cervical Cancer: A Phase 3 Prospective Multicenter Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2026 Feb 1;124(2):349-358. doi: 10.1016/j.ijrobp.2025.08.045. Epub 2025 Aug 26.

    PubMed 40876576

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ReSpace™ and gauze packing in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fuquan Zhang, doctor (+86 13311360431, zhangfuquan3@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The cumulative D2cc dose for rectum during brachytherapy (time frame: during procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05690906, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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