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

Peking University Third Hospital66 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rectum Cancer, Recurrent Brachytherapy, Radioisotope

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * serious medical illness * unable to tolerate anesthesia * blood coagulation dysfunction

Outcomes

Primary Outcomes

Overall survival time

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.

Time frame: 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.

Local control time

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.

Time frame: 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.

Secondary Outcomes

Pain relief rate

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.

Time frame: 3 months after the implantation. The last follow-up point is February 2019.

Incidence of adverse events

The adverse events were evaluated by the toxicity criteria of the Radiation Therapy Oncology Group (RTOG). The rate of each adverse event was measured.

Time frame: 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.