Clinical trial NCT03890926: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectum Cancer, Recurrent
Brachytherapy, Radioisotope
Keywords: Three-Dimensional Printing
Rectum Cancer, Recurrent
Radioactive Iodine-125 seed implantation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with local recurrent rectal carcinoma who were treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy as a conventional treatment in Peking University Third Hospital during December 2015 to December 2018

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival time
timeFrame: 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.
measure: Local control time
timeFrame: 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:
measure: Pain relief rate
timeFrame: 3 months after the implantation. The last follow-up point is February 2019.
measure: Incidence of adverse events
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Radiotherapy Department,Peking University Third Hospital
name: junjie wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.