The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

June 5, 2023 updated by: Peking Union Medical College Hospital

A Prospective, Multicenter, Exploratory Clinical Study to Evaluate the Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

This study is an exploratory study based on the previous study " A prospective, multicenter, randomized, parallel arm-controlled, superiority clinical study to evaluate the role of hydrogel spacer in reducing rectal radiation dose in cervical cancer radiation therapy", in which additional follow up study on the subjects of the previous study were conducted. Subjects (6 subjects in Phase I; 100 subjects in Phase II, 50 in the test group and 50 in the control group) who completed the pre-study will be enrolled in this study if they are willing to participate in the long-term follow-up by signing the informed consent form.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the long-term benefit of hydrogel spacer when hydrogel is injected between the rectum and cervix in women undergoing radiation therapy.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydrogel spacer
The Subjects randomized to the treatment group underwent placement of hydrogel spacer.
Device: hydrogel spacer
Randomly assigned to either the treatment group, who were injected with hydrogel spacer, or the control group, who were not injected with hydrogel spacer.
No Intervention: Control
The Subjects randomized to the control group did not receive injection of the hydrogel spacer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The stability of the hydrogel spacer
Time Frame: Through study completion, an average of 12 months
In order to verify the stability of the hydrogel spacer, this test will be based on MRI T2-weighed images.
Through study completion, an average of 12 months
Scores from Quality of Life Questionnaire-Core 30 Rating (QLQ-C30)
Time Frame: through study completion, an average of 12 months
European Organization for Research on Treatment of Cancer (EORTC) QLQ-C30 is a comprehensive survey instrument designed to assesses the disease-specific aspects of cervical cancer and its therapies. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
through study completion, an average of 12 months
Scores from Quality of Life Core Questionnaire Cervix Cancer Module 24 (QLQ-CX24)
Time Frame: through study completion, an average of 12 months
European Organization for Research on Treatment of Cancer (EORTC) QLQ-CX24 will be used to assess subjects' quality of life. EORTC QLQ-CX24 score from 0 to 100, higher scores indicate better quality of life or more symptoms.
through study completion, an average of 12 months
Percentage of subjects with ≥2 grade chronic radiation rectal injury
Time Frame: through study completion, an average of 12 months
The percentage of subjects in the treatment and control groups who had ≥ grade 2 chronic radiation rectal injury after radiation therapy will be calculated and compared between the groups.
through study completion, an average of 12 months
Adverse events requiring special attention
Time Frame: through study completion, an average of 12 months
The number of cases of adverse events requiring special attention related to radiation intestinal injury and the number of subjects having the above adverse events will be recorded in both the treatment and control groups.
through study completion, an average of 12 months
The number of (serious) adverse events, (serious) device-related adverse events
Time Frame: through study completion, an average of 12 months
The frequency (number of events) of occurrence of (serious) adverse events and device-related (serious) adverse events will be recorded for the entire study period.
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Shanghai Reunion Biotech Co.,Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN-CT-003

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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