Efficacy and Safety of Low Molecular Weight Hyaluronate gel spacer for Radiation Therapy of Gynecological Cancer

JRCT ID: jRCTs071230118

Registered date:27/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Cervical cancer, uterine cancer, vaginal cancer, and vulvar cancer
• Date of first enrollment: 27/02/2024
• Target sample size: 95
• Study type: Interventional
• Intervention(s): Transrectal ultrasound-guided transvaginal hyaluronate gel injection into the rectovaginal and cystovaginal septum

Outcome(s)

• Primary Outcome: 5-year cumulative rectal bleeding rate

Secondary Outcome

Early safety
Cumulative 2-year and 5-year disease-free survival rate
2 and 5-year cumulative overall survival rate
2 and 5-year cumulative local control rate
2-year cumulative rectal bleeding rate
2 and 5-year cumulative bladder bleeding rate
Tumor (target) dose parameters
D90%: The minimum dose covering 90% of the target volume
D98%: The minimum dose covering 98% of the target volume (=minimum dose)
V100%: the percentage of the target volume receiving 100% of the prescription dose
D2cc: the maximum dose to the most exposed 2.0 cm3 of the normal organs (rectum, urinary bladder, sigmoid colon)
Anatomical parameters
Minimum distance from the target (tumor, uterus, or vagina) to the bladder and rectum, the minimum distance to the bladder and rectum with a safety zone of 5 mm, and tumor volume

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Miyata Yusaku