Spots Global Cancer Trial Database for The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.
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Trial Identification
Brief Title: The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.
Official Title: 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.
Study ID: NCT05902390
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Peking Union Medical College Hospital, Beijing, , China
Contact Details
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