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

Peking University Third Hospital50 enrolled

Overview

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

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 .

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Peking University Third Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 years

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.

Time frame: three months

Secondary Outcomes

Overall survival

Overall survival was defined as the time from the implantation of the treatment to the death of any cause.

Time frame: 2 years

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.

Time frame: 2 years

Central Contacts

Ping Jiang, MD

CONTACT

13439796018 drjiangping@qq.com

Junjie Wang, MD, PhD

CONTACT

13701076310 junjiewang_edu@sina.cn

Data from ClinicalTrials.gov

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