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BioXmark, Rectal Feasibility Trial

NCT03265418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-04

No results posted yet for this study

Summary

To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.

Conditions

Interventions

DEVICE

BioXmark liquid fiducial markers

Before the start of the treatment planning during an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).

OTHER

Imaging

As part of standard patient set-up directly before each radiotherapy treatment, kV cone-beam CTs will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe, positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum. For patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device. As part of standard clinical practice an MR of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.

PROCEDURE

surgery or wait-and-see

As part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the "wait-and-see" protocol.

Sponsors & Collaborators

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Maaike Berbée, MD,PhD · Maastro Clinic, The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2019-07-25
Completion
2019-07-25

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265418 on ClinicalTrials.gov