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

NCT03890926 | Completed

• 1 other identifier: PekingUTH RT
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectum Cancer, Recurrent; Brachytherapy, Radioisotope

Keywords

Three-Dimensional Printing; Rectum Cancer, Recurrent; Radioactive Iodine-125 seed implantation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain relief rate

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

• 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.

Study Arms (1)

radioactive Iodine-125 seed implantation

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

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

Interventions

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

radioactive Iodine-125 seed implantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Related Publications (2)

• 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.

  PMID: 22004599 BACKGROUND

• 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.

  PMID: 32711542 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• junjie wang, Ph.D

  Radiotherapy Department,Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 26, 2019
• Study Start: December 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available within 6 months of the study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.