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

NCT04127435 | Unknown

• 1 other identifier: M2019338-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall survival

  2 years

• Safety and Tolerability

  2 years

Study Arms (1)

High-Dose-Rate 192Ir Brachytherapy

1. All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System. 2. Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs); 3. 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. 4. Depending on B-TPS data, we establish a digital model for the individual template. 5. 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. 6. Delineation of the GTV and design planning . 7. Connect the source tube and 192Ir high dose rate interorganizational brinotherapy 8. At the end pressed to stop bleeding.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed pelvic recurrence of cervical cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (2)

Peking University Third Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ping Jiang, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Jiang, MD

CONTACT

13439796018; drjiangping@qq.com

Junjie Wang, MD, PhD

CONTACT

13701076310; junjiewang_edu@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: October 15, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 15, 2019

Record last verified: 2019-08

Locations

CN (2)