High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors
- Conditions
- Cervical Cancer
- Registration Number
- NCT04127435
- Lead Sponsor
- Peking University Third Hospital
- 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Local Progression Free Survival 2 years Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.
Tumor Response Rate three months 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.
- Secondary Outcome Measures
Name Time Method Overall survival 2 years Overall survival was defined as the time from the implantation of the treatment to the death of any cause.
Safety and Tolerability 2 years 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.
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, China