Head and Neck NeoplasmMASSCNCT05011500

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

A study testing Radiotherapy with Closed Mask, Radiotherapy with Open Mask and Surface Scanning and Radiotherapy with No Mask in people with Head and Neck Neoplasm, run by Cancer Research Antwerp at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Neoplasm
What is being tested?: Radiotherapy with Closed Mask, Radiotherapy with Open Mask and Surface Scanning and Radiotherapy with No Mask
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteBelgium
Study dates: 1 Jun 2021to 1 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Daan Nevens, PhD contact

0032034433737 ext. +32

Daan.Nevens@gza.be

Belgium1 site, 1 recruiting

GZA Ziekenhuizen campus Sint-Augustinus
Antwerp, 2610
Daan Nevens, PhD, 0032034433737 ext. +32, Daan.Nevens@gza.be
Daan Nevens, PhD
Recruiting

Other trials in Belgium

About this study

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

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.

Conditions: Head and Neck Neoplasm
Being tested: Radiotherapy with Closed Mask, Radiotherapy with Open Mask and Surface Scanning, Radiotherapy with No Mask
Keywords: Radiotherapy, Radiotherapy, Image-Guided
Medical subject headings: Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiotherapy with Closed MaskRadiation
Also called Full thermoplastic mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
Radiotherapy with Open Mask and Surface ScanningRadiation
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 MaskRadiation
Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.

Study groups in NCT05011500
Study group	Role	What they receive
Starting with closed mask	Experimental	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. Receives: Radiation: Radiotherapy with Closed Mask; Radiation: Radiotherapy with Open Mask and Surface Scanning; Radiation: Radiotherapy with No Mask
Starting with open mask	Experimental	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. Receives: Radiation: Radiotherapy with Closed Mask; Radiation: Radiotherapy with Open Mask and Surface Scanning; Radiation: Radiotherapy with No Mask
Starting with no mask	Experimental	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. Receives: Radiation: Radiotherapy with Closed Mask; Radiation: Radiotherapy with Open Mask and Surface Scanning; Radiation: Radiotherapy with No Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Secondary outcomes (4)

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.
Measured: Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Duration of Treatment
Duration of treatment (in minutes), registered in radiotherapy software.
Measured: Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Radiotherapy Technician Satisfaction
Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome.
Measured: Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
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).
Measured: Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20211 May 2022

First posted18 Aug 2021
Study start1 Jun 2021
Primary completion1 May 2022 (estimated)
Study completion1 May 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05011500
Sponsor's protocol ID: CTOR20051GZA
Acronym: MASSC
Status last verified: Aug 2021
First submitted: 29 Apr 2021
Last updated: 18 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24399786
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.
PubMed 27025164
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.
PubMed 24036878
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.
PubMed 29119677
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.
PubMed 33458273
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.
PubMed 20714089
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.
PubMed 24068172
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.
PubMed 20224158
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.
PubMed 27890346
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.
PubMed 14752733

Want to know more?

Daan Nevens, PhD

0032034433737 ext. +32

Daan.Nevens@gza.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Head and Neck Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)
ClinicalTrials.gov ID: NCT05011500
Acronym / sponsor ID: MASSC / CTOR20051GZA
Conditions: Head and Neck Neoplasm
Keywords: Radiotherapy, Radiotherapy, Image-Guided
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Cancer Research AntwerpUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 1 May 2022 (estimated)
Study completion: 1 May 2022 (estimated)
First posted: 18 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Starting with closed mask	Experimental	Radiation: Radiotherapy with Closed Mask, Radiation: Radiotherapy with Open Mask and Surface Scanning, Radiation: Radiotherapy with No MaskPatient 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.
Starting with open mask	Experimental	Radiation: Radiotherapy with Closed Mask, Radiation: Radiotherapy with Open Mask and Surface Scanning, Radiation: Radiotherapy with No MaskPatient 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.
Starting with no mask	Experimental	Radiation: Radiotherapy with Closed Mask, Radiation: Radiotherapy with Open Mask and Surface Scanning, Radiation: Radiotherapy with No MaskPatient 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiotherapy with Closed MaskAlso: Full thermoplastic maskRadiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.	Radiation	Starting with closed mask, Starting with no mask, Starting with open mask
Radiotherapy with Open Mask and Surface ScanningRadiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.	Radiation	Starting with closed mask, Starting with no mask, Starting with open mask
Radiotherapy with No MaskRadiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.	Radiation	Starting with closed mask, Starting with no mask, Starting with open mask

Primary outcome

Positional Deviation
Time frame: Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
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).

4 secondary outcomes

Patient Distress
Time frame: Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Duration of Treatment
Time frame: Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Radiotherapy Technician Satisfaction
Time frame: Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
Radiation Dose
Time frame: Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Background: PubMed 24399786Siegel 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.
Background: PubMed 27025164Wiant 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.
Background: PubMed 24036878Li 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.
Background: PubMed 29119677Zhao 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.
Background: PubMed 33458273Dekker 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.
Background: PubMed 20714089Ali 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.
Background: PubMed 24068172Stieler 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.
Background: PubMed 20224158Cervino 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.
Background: PubMed 27890346Bartlett 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.
Background: PubMed 14752733van Herk M. Errors and margins in radiotherapy. Semin Radiat Oncol. 2004 Jan;14(1):52-64. doi: 10.1053/j.semradonc.2003.10.003.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daan Nevens, PhD contact

0032034433737 ext. +32

Daan.Nevens@gza.be

Daan Nevens, PhD principal investigator

Cancer Research Antwerp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Daan Nevens, PhD (0032034433737 ext. +32, Daan.Nevens@gza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positional Deviation (time frame: Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011500, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.