Efficacy and Safety of Low Molecular Weight Hyaluronate gel spacer for Radiation Therapy of Gynecological Cancer
- Conditions
- Cervical cancer, uterine cancer, vaginal cancer, and vulvar cancer
- Registration Number
- JPRN-jRCTs071230118
- Lead Sponsor
- Miyata Yusaku
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 95
1) Patients with gynecological cancer (cervical cancer, uterine body cancer, vaginal cancer, vulvar cancer) who are eligible for radical radiotherapy and meet any of the following conditions (i) to (iii)
(i) Adenocarcinoma or adenosquamous carcinoma
(ii) Extends more than 2 cm from the vaginal fornix to the lower part of the vagina and requires the use of a cylinder applicator.
(iii) Patients with a high radiation dose to the rectum, bladder, sigmoid colon, or small intestine after initial high-dose-rate brachytherapy without hyaluroniate gel injection and who are expected to have a high rate of adverse reactions if the treatment is continued.
2) Patients must be at least 18 years old.
3) Patients with or without symptoms
4) Patients with any pre-existing medical conditions (except in the case of an allergy to hyaluronate gel)
5) No contrast media if renal dysfunction (eGFR<50 ml/min/1.73 m2) or contrast media allergy
6) Threshold values should not be set based on clinical laboratory values, etc.
7) The patient may consent to the procedure. However, if the patient has expressed the intention to consent but is unable to sign, a guardian, guarantor, or legal representative may sign in place of the patient's signature.
1) Patients who are eligible for palliative radiation therapy.
2) Patients who do not have the capacity to consent.
3) Patients with allergic symptoms to hyaluronate gel.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method