The study of radiotherapy for gynecological tumors using lipiodol

JRCT ID: jRCTs021190022

Registered date:20/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical cancer, Vaginal cancer
• Date of first enrollment: 05/06/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Injection of lipiodol at 2-3 mm under the submucosa at two or three point around the tumor.

Outcome(s)

• Primary Outcome: Evaluation of safety by injection of ethyl ester of iodinated poppy-seed oil fatty acid.

Secondary Outcome

Evaluation of retention period by injecting ethyl ester of iodinated poppy-seed oil fatty acid.
Evaluated of contouring by injection of ethyl ester of iodinated poppy-seed oil fatty acid.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female

Include criteria

(1) Cervical cancer, Vaginal cancer
(2) Patients with indications for definitive radiotherapy
(3) Age between 20 and 80 years old
(4) ECOG performance status 0-2
(5) No prior abdominopelvic irradiation
(6) It is possible to stop taking or do not intake any anticoagulant or antiplatelet
(7) Patients with sufficient organ function
- neutrophil count greater than 2,000/mm3
- hemoglobin greater than 8g/dL
- platelets greater than 50,000/mm3
- albumin greater than 3.0 g/dL
- total bilirubin lower than 2.0mg/dL
- AST (GOT) and ALT (GPT) lower than 150 IU/L
-serum creatinine lower than 1.2mg/dL
(8) Patient must provide study-specific informed consent prior to study entry

Exclude criteria

(1) Severe comorbidities (such as heart failure, renal failure, hepatic failure, respiratory dysfunction, lymph duct obstruction, poorly controlled diabetes and poorly controlled hypertension)
(2) Active thyroid disease
(3) Pyrexia of 38 degrees centigrade or higher.
(4) An allergy to iodine drugs
(5) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
(6) Psychiatric comorbidities or problems hinders enrollment of the study
(7) Attending physician believes the patient is not suitable for the study

Related Information

• Primary Sponsor: Umezawa Rei
• Source(s) of Monetary Support: Japan mHDR Research Fund