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

NCT ID: NCT03890926

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-02-28

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.

Conditions

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Rectum Cancer, Recurrent Brachytherapy, Radioisotope

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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radioactive Iodine-125 seed implantation

All enrolled patients received the intervention previously as a conventional treatment.

radioactive Iodine-125 seed implantation under the guidance of 3D template

Intervention Type RADIATION

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.

Interventions

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radioactive Iodine-125 seed implantation under the guidance of 3D template

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.

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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junjie wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Radiotherapy Department,Peking University Third Hospital

References

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Wang Z, Lu J, Liu L, Liu T, Chen K, Liu F, Huang G. Clinical application of CT-guided (125)I seed interstitial implantation for local recurrent rectal carcinoma. Radiat Oncol. 2011 Oct 18;6:138. doi: 10.1186/1748-717X-6-138.

Reference Type BACKGROUND
PMID: 22004599 (View on PubMed)

Wang L, Wang H, Jiang Y, Ji Z, Guo F, Jiang P, Li X, Chen Y, Sun H, Fan J, Li W, Li X, Wang J. The efficacy and dosimetry analysis of CT-guided 125I seed implantation assisted with 3D-printing non-co-planar template in locally recurrent rectal cancer. Radiat Oncol. 2020 Jul 25;15(1):179. doi: 10.1186/s13014-020-01607-2.

Reference Type DERIVED
PMID: 32711542 (View on PubMed)

Other Identifiers

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PekingUTH RT

Identifier Type: -

Identifier Source: org_study_id

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