Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

Head and Neck Neoplasm Clinical Trial

— MASSC  

Official title:

Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05011500
• Other study ID #: CTOR20051GZA
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2021
• Source: Cancer Research Antwerp
• Contact: Daan Nevens, PhD
• Phone: 0032034433737
• Email: Daan.Nevens[@]gza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Radiation:
• Radiotherapy with Closed Mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
• Radiotherapy with Open Mask and Surface Scanning
Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
• Radiotherapy with No Mask
Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.

Locations

Country	Name	City	State
Belgium	GZA Ziekenhuizen campus Sint-Augustinus	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

Ali I, Matthiesen C, Algan O, Thompson S, Bogardus C, Herman T, Ahmad S. Quantitative evaluation of increase in surface dose by immobilization thermoplastic masks and superficial dosimetry using Gafchromic EBT film and Monte Carlo calculations. J Xray Sci Technol. 2010;18(3):319-26. doi: 10.3233/XST-2010-0263. — View Citation

Bartlett FR, Donovan EM, McNair HA, Corsini LA, Colgan RM, Evans PM, Maynard L, Griffin C, Haviland JS, Yarnold JR, Kirby AM. The UK HeartSpare Study (Stage II): Multicentre Evaluation of a Voluntary Breath-hold Technique in Patients Receiving Breast Radiotherapy. Clin Oncol (R Coll Radiol). 2017 Mar;29(3):e51-e56. doi: 10.1016/j.clon.2016.11.005. Epub 2016 Nov 24. — View Citation

Cerviño LI, Pawlicki T, Lawson JD, Jiang SB. Frame-less and mask-less cranial stereotactic radiosurgery: a feasibility study. Phys Med Biol. 2010 Apr 7;55(7):1863-73. doi: 10.1088/0031-9155/55/7/005. Epub 2010 Mar 12. — View Citation

Dekker J, Rozema T, Böing-Messing F, Garcia M, Washington D, de Kruijf W. Whole-brain radiation therapy without a thermoplastic mask. Phys Imaging Radiat Oncol. 2019 Jul 25;11:27-29. doi: 10.1016/j.phro.2019.07.004. eCollection 2019 Jul. — View 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. — View Citation

Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7. Erratum in: CA Cancer J Clin. 2014 Sep-Oct;64(5):364. — View 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. — View Citation

van Herk M. Errors and margins in radiotherapy. Semin Radiat Oncol. 2004 Jan;14(1):52-64. Review. — View 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. — View Citation

Zhao B, Maquilan G, Jiang S, Schwartz DL. Minimal mask immobilization with optical surface guidance for head and neck radiotherapy. J Appl Clin Med Phys. 2018 Jan;19(1):17-24. doi: 10.1002/acm2.12211. Epub 2017 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positional Deviation	Patient positioning and movement during treatment will be assessed using cone-beam computed tomopgraphy (CBCT). The position of the patient and target volumes measured by CBCT will be compared to computed tomography (CT) scans made during the initial simulation of treatment. CBCT-scans are made right before administering radiation and after radiation has been administered. Translational and rotational deviations will be measured and expressed in millimeters (for translational deviation) and degrees (for rotational deviation).	Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary	Patient Distress	Patient Distress, measured every week using the Subjective Units of Distress Scale (SUDs), a scale of 0-10 where a higher number indicates a worse outcome.	Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary	Duration of Treatment	Duration of treatment (in minutes), registered in radiotherapy software.	Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary	Radiotherapy Technician Satisfaction	Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome.	Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary	Radiation Dose	In vivo dosimetry will be used to asses the accuracy of treatment. Using PerFRACTION™ in vivo dosimetry. Administered radiation doses will be measured for the target volume and expressed in Gray (Gy).	Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).