Clinical trial NCT05011500: Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)
Official title: Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Neoplasm
Keywords: Radiotherapy
Radiotherapy, Image-Guided
Lead sponsor: Cancer Research Antwerp
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the feasibility of using open masks or no masks in combination with optical surface scanning for radiotherapy in patients with head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old
* Histologically confirmed head and neck cancer.
* Patients treated with radiotherapy (RT) as primary treatment.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-1 as defined in Appendix 3.
* Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.
* Patients must be willing to comply with treatment plan and other study procedures

Exclusion Criteria:

* Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study.
* Patients who cannot stay still during fraction because of a disorder (e.g. Parkinson's disease)

Primary outcomes:
measure: Positional Deviation
timeFrame: Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary outcomes:
measure: Patient Distress
timeFrame: Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
measure: Duration of Treatment
timeFrame: Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
measure: Radiotherapy Technician Satisfaction
timeFrame: Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
measure: Radiation Dose
timeFrame: Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Augustinus
Study officials:
affiliation: Cancer Research Antwerp
name: Daan Nevens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wiant D, Squire S, Liu H, Maurer J, Lane Hayes T, Sintay B. A prospective evaluation of open face masks for head and neck radiation therapy. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e259-e267. doi: 10.1016/j.prro.2016.02.003. Epub 2016 Feb 13.
citation: Li G, Lovelock DM, Mechalakos J, Rao S, Della-Biancia C, Amols H, Lee N. Migration from full-head mask to "open-face" mask for immobilization of patients with head and neck cancer. J Appl Clin Med Phys. 2013 Sep 6;14(5):243-54. doi: 10.1120/jacmp.v14i5.4400.
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citation: Stieler F, Wenz F, Shi M, Lohr F. A novel surface imaging system for patient positioning and surveillance during radiotherapy. A phantom study and clinical evaluation. Strahlenther Onkol. 2013 Nov;189(11):938-44. doi: 10.1007/s00066-013-0441-z. Epub 2013 Sep 27.
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citation: van Herk M. Errors and margins in radiotherapy. Semin Radiat Oncol. 2004 Jan;14(1):52-64. doi: 10.1053/j.semradonc.2003.10.003.