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

Primary Purpose

Head and Neck Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Radiotherapy with Closed Mask
Radiotherapy with Open Mask and Surface Scanning
Radiotherapy with No Mask
Sponsored by
Cancer Research Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Neoplasm focused on measuring Radiotherapy, Radiotherapy, Image-Guided

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • GZA Ziekenhuizen campus Sint-AugustinusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Starting with closed mask

Starting with open mask

Starting with no mask

Arm Description

Patient 1-8, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using a closed mask. For the next 5 fractions these patients will receive radiotherapy using an open mask. For the 5 fractions after that these patients will receive radiotherapy using no mask. This schedule repeats for the rest of their treatment.

Patient 9-16, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using an open mask. For the next 5 fractions these patients will receive radiotherapy using no mask. For the 5 fractions after that these patients will receive radiotherapy using a closed mask. This schedule repeats for the rest of their treatment.

Patient 17-24, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using no mask. For the next 5 fractions these patients will receive radiotherapy using a closed mask. For the 5 fractions after that these patients will receive radiotherapy using an open mask. This schedule repeats for the rest of their treatment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Duration of Treatment
Duration of treatment (in minutes), registered in radiotherapy software.
Radiotherapy Technician Satisfaction
Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome.
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).

Full Information

First Posted
April 29, 2021
Last Updated
August 17, 2021
Sponsor
Cancer Research Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT05011500
Brief Title
Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)
Acronym
MASSC
Official Title
Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Research Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm
Keywords
Radiotherapy, Radiotherapy, Image-Guided

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Starting with closed mask
Arm Type
Experimental
Arm Description
Patient 1-8, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using a closed mask. For the next 5 fractions these patients will receive radiotherapy using an open mask. For the 5 fractions after that these patients will receive radiotherapy using no mask. This schedule repeats for the rest of their treatment.
Arm Title
Starting with open mask
Arm Type
Experimental
Arm Description
Patient 9-16, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using an open mask. For the next 5 fractions these patients will receive radiotherapy using no mask. For the 5 fractions after that these patients will receive radiotherapy using a closed mask. This schedule repeats for the rest of their treatment.
Arm Title
Starting with no mask
Arm Type
Experimental
Arm Description
Patient 17-24, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using no mask. For the next 5 fractions these patients will receive radiotherapy using a closed mask. For the 5 fractions after that these patients will receive radiotherapy using an open mask. This schedule repeats for the rest of their treatment.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with Closed Mask
Other Intervention Name(s)
Full thermoplastic mask
Intervention Description
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with Open Mask and Surface Scanning
Intervention Description
Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with No Mask
Intervention Description
Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
Primary Outcome Measure Information:
Title
Positional Deviation
Description
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).
Time Frame
Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Secondary Outcome Measure Information:
Title
Patient Distress
Description
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.
Time Frame
Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Title
Duration of Treatment
Description
Duration of treatment (in minutes), registered in radiotherapy software.
Time Frame
Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Title
Radiotherapy Technician Satisfaction
Description
Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome.
Time Frame
Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Title
Radiation Dose
Description
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).
Time Frame
Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daan Nevens, PhD
Phone
0032034433737
Ext
+32
Email
Daan.Nevens@gza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daan Nevens, PhD
Organizational Affiliation
Cancer Research Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
GZA Ziekenhuizen campus Sint-Augustinus
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daan Nevens, PhD
Phone
0032034433737
Ext
+32
Email
Daan.Nevens@gza.be
First Name & Middle Initial & Last Name & Degree
Daan Nevens, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24399786
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.
Results Reference
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PubMed Identifier
27025164
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.
Results Reference
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PubMed Identifier
24036878
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.
Results Reference
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PubMed Identifier
29119677
Citation
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Results Reference
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PubMed Identifier
33458273
Citation
Dekker J, Rozema T, Boing-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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
24068172
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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PubMed Identifier
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Citation
Cervino 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.
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PubMed Identifier
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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.
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Results Reference
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Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

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