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

NCT ID: NCT04127435

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

Brief Summary

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

Detailed 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 .

Conditions

Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High-Dose-Rate 192Ir Brachytherapy

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Ping Jiang, MD

Role: CONTACT

drjiangping@qq.com

13439796018

Junjie Wang, MD, PhD

Role: CONTACT

junjiewang_edu@sina.cn

13701076310

Facility Contacts

junjie wang, MD,PhD

Role: primary

junjiewang_edu@sina.cn

13701076310

Junjie Wang, MD,PhD

Role: primary

junjiewang_edu@sina.cn

13701076310

Other Identifiers

M2019338-1

Identifier Type: -

Identifier Source: org_study_id