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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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, a Retrospective Study

Conditions
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Rectum Cancer, Recurrent, Brachytherapy, Radioisotope

Intervention / Treatment
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* Radiation: radioactive Iodine-125 seed implantation under the guidance of 3D template


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| radioactive Iodine-125 seed implantation<br>All enrolled patients received the intervention previously as a conventional treatment. | Radiation: radioactive Iodine-125 seed implantation under the guidance of 3D template<br>* 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment for patients with local recurrent rectal carcinoma. Retrospective data on the effectiveness and adverse effects of the past radioactive Iodine-125 seed implantation is collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Three-Dimensional Printing, Rectum Cancer, Recurrent, Radioactive Iodine-125 seed implantation