NCT05011500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

April 29, 2021

Last Update Submit

August 17, 2021

Conditions

Head and Neck Neoplasm

Keywords

RadiotherapyRadiotherapy, Image-Guided

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient Distress

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

  • Radiotherapy Technician Satisfaction

    Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

  • Radiation Dose

    Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Study Arms (3)

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.

Radiation: Radiotherapy with Closed MaskRadiation: Radiotherapy with Open Mask and Surface ScanningRadiation: 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.

Radiation: Radiotherapy with Closed MaskRadiation: Radiotherapy with Open Mask and Surface ScanningRadiation: 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.

Radiation: Radiotherapy with Closed MaskRadiation: Radiotherapy with Open Mask and Surface ScanningRadiation: Radiotherapy with No Mask

Interventions

Radiotherapy with Closed MaskRADIATION

Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.

Also known as: Full thermoplastic mask
Starting with closed maskStarting with no maskStarting with open mask
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.

Starting with closed maskStarting with no maskStarting with open mask
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.

Starting with closed maskStarting with no maskStarting with open mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GZA Ziekenhuizen campus Sint-Augustinus

Antwerp, 2610, Belgium

RECRUITING

Related Publications (10)

  • 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.

    PMID: 24399786BACKGROUND

  • 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.

    PMID: 27025164BACKGROUND

  • 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.

    PMID: 24036878BACKGROUND

  • 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.

    PMID: 29119677BACKGROUND

  • 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.

    PMID: 33458273BACKGROUND

  • 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.

    PMID: 20714089BACKGROUND

  • 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.

    PMID: 24068172BACKGROUND

  • 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.

    PMID: 20224158BACKGROUND

  • 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.

    PMID: 27890346BACKGROUND

  • 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.

    PMID: 14752733BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daan Nevens, PhD

    Cancer Research Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daan Nevens, PhD

CONTACT

0032034433737Daan.Nevens@gza.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

August 18, 2021

Study Start

June 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)