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

Cervical Cancer Clinical Trial

Official title:

Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127435
• Other study ID #: M2019338-1
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Peking University Third Hospital
• Contact: Ping Jiang, MD
• Phone: 13439796018
• Email: drjiangping[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Genital Neoplasms, Female

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Progression Free Survival	Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.	2 years
Primary	Tumor Response Rate	Tumor size changes were monitored using CT. According to the solid tumor treatment efficacy evaluation standard RECIST, evaluation results including complete response, partial response, stable disease, and progression disease.Tumor response rate was complete response rate plus partial response rate.	three months
Secondary	Overall survival	Overall survival was defined as the time from the implantation of the treatment to the death of any cause.	2 years
Secondary	Safety and Tolerability	Number of participants with treatment-related acute adverse events were evaluated according to RTOG acute radiation injury grading standards; Number of participants with treatment-related late adverse events were evaluated according to RTOG/ EORTC advanced radiation injury grading schemes.	2 years