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

Sponsor
Cancer Research Antwerp (Other)
Overall Status
Recruiting
CT.gov ID
NCT05011500
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
11
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy with Closed Mask
  • Radiation: Radiotherapy with Open Mask and Surface Scanning
  • Radiation: Radiotherapy with No Mask
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Positional Deviation [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).

    Secondary Outcome Measures

    1. Patient Distress [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.

    2. Duration of Treatment [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.

    3. Radiotherapy Technician Satisfaction [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.

    4. Radiation Dose [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GZA Ziekenhuizen campus Sint-Augustinus Antwerp Belgium 2610

    Sponsors and Collaborators

    • Cancer Research Antwerp

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Cancer Research Antwerp
    ClinicalTrials.gov Identifier:
    NCT05011500
    Other Study ID Numbers:
    • CTOR20051GZA
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Aug 18, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Cancer Research Antwerp
    Radiotherapy
    Radiotherapy, Image-Guided
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2021