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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
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.
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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.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Local Progression Free Survival2 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 Ratethree 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
NameTimeMethod
Overall survival2 years

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

Safety and Tolerability2 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

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