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Trial Title:
Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
NCT ID:
NCT05690906
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical Cancer
Hydrogel Spacer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ReSpace™
Description:
The experimental group subjects will be injected with ReSpace™ hydrogel.
Arm group label:
ReSpace™ & gauze packing
Intervention type:
Device
Intervention name:
gauze packing
Description:
The subjects of both groups will be given gauze packing
Arm group label:
ReSpace™ & gauze packing
Arm group label:
gauze packing
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Junfang Yan, doctor
Phone:
+86 18611286276
Email:
yanjunfang@pumch.cn
Start date:
July 12, 2022
Completion date:
July 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690906
