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NCT05690906
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
Conditions: Uterine Cervical Neoplasms
Sex: Female
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 100
Sponsor: Peking Union Medical College Hospital
Location: China
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.
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 formExclusion 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 malignanciesSubjects with contraindications to radiotherapy, as determined by the investigatorsSubjects 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 investigatorsPersons with severe mental illness, cognitive impairment and thinking disorders.Participants in other drug clinical trials or medical device clinical trials 1 month prior to screeningPregnant or lactating women or those who plan to get pregnant within the last six monthsSubjects who cannot be followed up as prescribed by the doctorOther conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
Source: ClinicalTrials.gov (NCT05690906). StuddyBuddy aggregates publicly available trial information.