Clinical trial NCT03265418: BioXmark, Rectal Feasibility Trial
Official title: BioXmark Liquid Fiducials to Enable Radiotherapy Tumor Boosting in Rectal Cancer, a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is a prospective non-randomized open label trial.

A total of 20 patients who will undergo neo-adjuvant chemo-radiotherapy for rectal cancer will be included in this study upon informed consent.

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).

Participants will undergo standard treatment for their rectal cancer.

As part of standard patient set-up directly before each radiotherapy treatment, kilovoltage (KV) cone-beam computed tomography (CBCT) 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 (this probe will be positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum). Moreover, 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 Magnetic resonance imaging (MRI) of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.

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.

Cone-beam CT and MR images which are obtained as routine practice during treatment of the participants will be compared with images of 20 non-participating patients treated at our institute in the same period.

Eligibility criteria: Inclusion Criteria:

* Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy
* Age \> 18 years
* Have given written informed consent before patient registration

Exclusion Criteria:

* Patients using anticoagulants: platelet aggregation inhibitors or coumarines
* Iodine allergy

Primary outcomes:
measure: Positional stability of BioXmark liquid fiducial markers during the treatment course
timeFrame: will be determined through the course of radiotherapy, an average of 5 weeks
Secondary outcomes:
measure: Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course
timeFrame: will be determined for the time interval between placement and the post-treatment MRI, an average of 12 weeks
measure: Percentage of markers lost from injection to CT acquisition for RT planning
timeFrame: will be determined for the time interval between placement and pretreatment radiotherapy planning CT, an average of 1 week
measure: Percentage of markers lost from injection to CT acquisition for RT planning
timeFrame: will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks
measure: Adverse events (AE) potentially associated with BioXmark
timeFrame: until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.
measure: Inter-observer variation in gross tumor volume (GTV) localization with and without markers
timeFrame: through the course of radiotherapy, an average of 5 weeks
measure: Effect of BioXmark liquid fiducial markers on post-treatment MRI images
timeFrame: at the moment of the post-treatment MRI, on average 6-8 weeks after chemo-radiation
measure: Potential BioXmark induced alterations in the surgical specimen
timeFrame: on average 10-12 weeks after chemo-radiation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO Clinic
state: Limburg
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Maaike Berbée, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: