The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy

Completed

• Conditions: Rectum Cancer, Recurrent; Brachytherapy, Radioisotope
• Interventions: Radiation: radioactive Iodine-125 seed implantation under the guidance of 3D template

• Registration Number: NCT03890926
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

Detailed Description

3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. 3D-printing non co-planar template is made individually which guides the implantation of Iodine-125 seed into the tumor and ensures the accuracy of the position.This study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-03
• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy in Peking University Third Hospital
• histological proven recurrent rectal cancer
• inoperable local recurrent cases
• previous external beam radiotherapy, incapable of re-irradiation
• expected life span>3 months

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Exclusion Criteria

• serious medical illness
• unable to tolerate anesthesia
• blood coagulation dysfunction

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
radioactive Iodine-125 seed implantation	radioactive Iodine-125 seed implantation under the guidance of 3D template	All enrolled patients received the intervention previously as a conventional treatment.

Primary Outcome Measures

Name	Time	Method
Local control time	From date of implantation to the date of recurrence of the implanted tumor or the date of last observation. The last follow-up timepoint is February 2019.	The time from the date of implantation to the date of recurrence of the implanted tumor or the date of last observation. Outcomes were followed up every 3 months after enrollment.
Overall survival time	From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.	The time from the date of implantation to the date of death from any cause or the date of last observation. Outcomes were followed up every 3 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Pain relief rate	3 months after the implantation. The last follow-up point is February 2019.	Numerical rating scales(NRS) was used to evaluate the grade of pain. Grade 7-9 was defined as serve pain. Grade 4-6 was defined as moderate pain and grade 1-3 was defined as mild pain. The pain before and after the implantation was evaluated and the pain relief rate was measured.
Incidence of adverse events	From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.	The adverse events were evaluated by the toxicity criteria of the Radiation Therapy Oncology Group (RTOG). The rate of each adverse event was measured.