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Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in volumetric-arc radiotherapy (VMAT) for head and neck cancer. This trial (RADPAINT) investigates the safety of FDG-PET guided radiotherapy using VMAT dose-painting by contours for patients with head and neck cancer of poor prognosis.
In this study, radiotherapy is planned using 18F-FDG PET/CT (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" SIB (simultaneous integrated boost) plan with a maximum point dose of 83 Gy. The participants will be given 73 Gy and 78 Gy minimum doses to two GTVs (gross tumor volumes inside the conventional GTV (68 Gy). GTV_73Gy and GTV_78Gy are determined from the SUV (standardized uptake values) from the 18F-FDG PET/CT according to the formula proposed by the Ghent group (Van der Straeten et al, R&O -06). It is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 Gy).
In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT (3 months after treatment and toxicity scoring at 6 weeks, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose painting | Experimental | Dose painting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG-PET guided dose painting | Radiation | The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET. |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity - mucosal ulcer | The study will be stopped if ≥ 2 patients experience mucosal ulcers grade ≥ 3 (CTCAE v 3.0/v4.0) without healing within the first year after radiotherapy. This endpoint will be assessed by clinical examination. | 1 year |
| Acute or late toxicity | Any life-threatening toxicity (CTCAE v4.0) related to radiotherapy. This endpoint will be assessed by clinical examination. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | CTCAE v4.0 | < 3 months after radiotherapy |
| Late toxicity | CTCAE v4.0 | 1 year |
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Inclusion Criteria:
Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Oral cavity, hypopharynx cancer, larynx cancer and HPV ((human papillomavirus) negative oropharyngeal cancer.
Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer)
Planned treatment at the Oslo University Hospital
Age > 18 years
WHO (World Health Organization) performance status 0-2
Exclusion Criteria:
TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0
Glottic cancer cT1-T2 cN0 cM0
HPV positive oropharyngeal carcinoma
Cancer in the soft palate
Diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Stein Kaasa, MD PhD | Oslo University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34991431 | Result | Evensen ME, Furre T, Malinen E, Londalen AM, Dale E. Mucosa-sparing dose painting of head and neck cancer. Acta Oncol. 2022 Feb;61(2):141-145. doi: 10.1080/0284186X.2021.2022200. Epub 2022 Jan 6. No abstract available. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Loco-regional control | FDG PET/CT at 3 months. Imaging thereafter if clinical progression. | 3 years |
| Disease free survival | FDG PET/CT at 3 months. Imaging thereafter if clinical progression. | 3 years |
| Overall survival | Date from central registry. | 3 years |