Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy with Closed Mask | Radiation | Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks). |
| Duration of Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daan Nevens, PhD | Contact | 0032034433737 | +32 | Daan.Nevens@gza.be |
| Name | Affiliation | Role |
|---|---|---|
| Daan Nevens, PhD | Cancer Research Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GZA Ziekenhuizen campus Sint-Augustinus | Recruiting | Antwerp | 2610 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24399786 | Background | 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. | |
| 27025164 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2021 | Aug 12, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Radiotherapy with Open Mask and Surface Scanning | Radiation | 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 Mask | Radiation | Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning. |
|
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 | 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 | 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). |
| 24036878 | Background | 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. |
| 29119677 | Background | 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. |
| 33458273 | Background | 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. |
| 20714089 | Background | 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. |
| 24068172 | Background | 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. |
| 20224158 | Background | 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. |
| 27890346 | Background | 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. |
| 14752733 | Background | 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. |