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

August 17, 2021 updated by: Cancer Research Antwerp

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Antwerp, Belgium, 2610
        • Recruiting
        • GZA Ziekenhuizen campus Sint-Augustinus
        • Contact:
        • Principal Investigator:
          • Daan Nevens, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Starting with closed mask
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 Mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
Other Names:
  • Full thermoplastic mask
Radiation: 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.
Radiation: 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.
Experimental: Starting with open mask
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 Mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
Other Names:
  • Full thermoplastic mask
Radiation: 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.
Radiation: 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.
Experimental: Starting with no mask
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 Mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
Other Names:
  • Full thermoplastic mask
Radiation: 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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Distress
Time Frame: Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
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).
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).
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).
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).
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).
Radiation Dose
Time Frame: Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research Antwerp

Investigators

  • Principal Investigator: Daan Nevens, PhD, Cancer Research Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTOR20051GZA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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