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

Cancer Research Antwerp

Status: Unknown

Conditions: Head and Neck Neoplasm

Treatments: Radiation: Radiotherapy with Closed Mask; Radiation: Radiotherapy with No Mask; Radiation: Radiotherapy with Open Mask and Surface Scanning

Study type: Interventional

Funder types: Other

Identifiers

NCT05011500

CTOR20051GZA

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Starting with closed mask

Experimental group

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.

Treatment:

Radiation: Radiotherapy with Closed Mask

Radiation: Radiotherapy with No Mask

Radiation: Radiotherapy with Open Mask and Surface Scanning

Starting with open mask

Experimental group

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.

Treatment:

Radiation: Radiotherapy with Closed Mask

Radiation: Radiotherapy with No Mask

Radiation: Radiotherapy with Open Mask and Surface Scanning

Starting with no mask

Experimental group

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.

Treatment:

Radiation: Radiotherapy with Closed Mask

Radiation: Radiotherapy with No Mask

Radiation: Radiotherapy with Open Mask and Surface Scanning