High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors

Peking University

Status: Unknown

Conditions: Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04127435

M2019338-1

Details and patient eligibility

About

This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .

Full description

The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed pelvic recurrence of cervical cancer.
• Age ≥ 18 years and ≤ 75 years.
• Previous accept pelvic radiotherapy;
• Karnofsky ≥60；
• Patients reject or cannot tolerate surgery;
• Received 192Ir high dose rate intertissue salvage therapy;
• Ultrasound guidance or computed tomography guidance;
• Regular review and follow-up.

Exclusion criteria

• Patients participated in clinical trials of other drugs within four weeks;
• The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
• There are any puncture taboos.
• Patients with severe cardiovascular and cerebrovascular diseases.
• Unable to treat as planned.
• Patients lack major indicators and cannot participate in post-treatment review and follow-up.

Trial design

50 participants in 1 patient group

High-Dose-Rate 192Ir Brachytherapy

Description:

1. All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System. 2. Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs); 3. Determination of the needle tract of the implanted insertion direction, distribution, and depth. Then calculation of the dose distribution of the target volume and OARs. 4. Depending on B-TPS data, we establish a digital model for the individual template. 5. Local anesthesia or intraspinal anesthesia was induced in all patients. The three-dimensional printing noncoplanar templates (3D-PNCT) was placed on the surface of the treatment area of the patient. The 3D-PNCT was aligned accurately with the outer-contour features. Through the guide hole of the 3D-PNCT, we inserted to pre-planned depths. 6. Delineation of the GTV and design planning . 7. Connect the source tube and 192Ir high dose rate interorganizational brinotherapy 8. At the end pressed to stop bleeding.