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The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.
Specific objectives
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy (primary or postoperative) | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity | Late toxicity | At 6 months after last day of completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in acute toxicity | Change in acute toxicity | At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy |
| Change in patient-rated quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with head and neck cancer planned for curatively intended primary or postoperative radiotherapy will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J.A. Langendijk, Prof. Dr. | Contact | +31503615532 | j.a.langendijk@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| J.A. Langendijk, Prof. Dr. | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9700RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39716592 | Derived | van der Laan HP, Gawryszuk A, van der Schaaf A, Langendijk JA. Risk reduction of radiation-induced aspiration by sparing specific aspiration-related-organs at risk; an in silico feasibility study. Radiother Oncol. 2025 Feb;203:110698. doi: 10.1016/j.radonc.2024.110698. Epub 2024 Dec 21. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
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Change in patient-rated quality of life
| At 6,12,18,24,36,48,60 months after completion of treatment |
| Overall survival | Overall survival | At 1,2,3,4 and 5 years after completion of treatment |
| Change in locoregional tumour control | Change in locoregional tumour control | At 1,2,3,4 and 5 years after completion of treatment |
| Laryngo-oesophageal dysfunction-free survival | Laryngo-oesophageal dysfunction-free survival | At 1,2,3,4 and 5 years after completion of treatment |
| Change in patient-rated symptoms | Change in patient-rated symptoms | At 1,2,3,4,5,6,7 (= during radiation therapy) and 12 weeks (= 6 weeks after completion of treatment) after first day of radiation therapy |
| Late toxicity | Late toxicity | At 12 months after last day of completion of treatment |
| Late toxicity | Late toxicity | At 18 months after last day of completion of treatment |
| Late toxicity | Late toxicity | At 24 months after last day of completion of treatment |
| Late toxicity | Late toxicity | At 36 months after last day of completion of treatment |
| Late toxicity | Late toxicity | At 48 months after last day of completion of treatment |
| Late toxicity | Late toxicity | At 60 months after last day of completion of treatment |
| Thyroid Stimulating Hormone (TSH) | TSH levels (mU/L) measured in blood | At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy. |
| Free Thyroxine-4 (FT4) | FT4 levels (pmol/L) measured in blood | At baseline and at 6, 12, 18, 24, 36, 48 and 60 months after completion of radiation therapy. |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |