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Trial Title:
The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.
NCT ID:
NCT05902390
Condition:
Uterine Cervical Neoplasms
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical Cancer
hydrogel spacer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
hydrogel spacer
Description:
Randomly assigned to either the treatment group, who were injected with hydrogel spacer,
or the control group, who were not injected with hydrogel spacer.
Arm group label:
hydrogel spacer
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
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:
June 2023
Completion date:
May 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Reunion Biotech Co.,Ltd.
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/NCT05902390
