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

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

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

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer

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 .

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ping Jiang, MD; Phone Number: 13439796018; Email: drjiangping@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Junjie Wang, MD,PhD; Phone Number: 13701076310; Email: junjiewang_edu@sina.cn
  • Beijing, China
    • Not yet recruiting
    • Peking University Third Hospital
    • Contact: Junjie Wang, MD,PhD; Phone Number: 13701076310; Email: junjiewang_edu@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed pelvic recurrence of cervical cancer.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

High-Dose-Rate 192Ir Brachytherapy; All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System.; Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs);; 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.; Depending on B-TPS data, we establish a digital model for the individual template.; 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.; Delineation of the GTV and design planning .; Connect the source tube and 192Ir high dose rate interorganizational brinotherapy; At the end pressed to stop bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival was defined as the time from the implantation of the treatment to the death of any cause.	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.	2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Ping Jiang, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female
• Other Study ID Numbers: M2019338-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No