ReIrradiation With FDG-PET Guided Dose Painting

Study Overview
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Brief Summary
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Dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (IMRT) for primary head and neck cancer. This could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. This trial (RIDPAINT) investigates the feasibility of FDG-PET guided radiotherapy using IMRT dose-painting by contours for patients with recurrent and second primary head and neck cancer.

Detailed Description
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The standard re-irradiation regimen for head and neck cancer patients treated at the Oslo University Hospital is 1.5 Gy twice daily during 4 weeks with a total dose of 60 Gy. In this study the radiotherapy is planned using 18F-FDG PET/CT making one experimental dose-painting by contours SIB (simultaneous integrated boost) plan with a maximum point dose of 75 Gy. The participants will be given 65 Gy and 70 Gy minimum doses to two GTVs inside the conventional GTV (60 Gy). GTV_65Gy and GTV_70Gy are determined from the SUV 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 60 Gy). In addition to the routine follow-up, the participants will be examined with 18F-FDG PET/CT 6 months after inclusion (4 1/2 months after end of radiotherapy) and HRQL measurements.

Official Title
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ReIrradiation With FDG-PET Guided Dose Painting for Recurrent and Second Primary Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: FDG-PET guided dose painting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C02.0 - C02.9; C03.0 - C03.9; C04.0 - C04.9; C05.0 - C05.9; C06.0 - C06.9; C09.0 - C09.9; C10.0 - C10.9; C11.0 - C11.9; C12; C13.0 - C13.9; C14.0 - C14.9; C30; C31.0 - C31.9; C32.0 - C32.9 Planned treatment at the Norwegian Radium Hospital or at other participating university hospitals Age ≥18 years Ability to understand and respond to the questionnaires Informed consent received Squamous cell carcinoma in the head and neck region of patients previously irradiated for head and neck cancer No grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy Minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer ECOG performance status ≤ 2 Exclusion Criteria: Patients planned for standard curative treatment (radical RT +/-concomitant chemotherapy or postoperative RT of primary disease) Patients who previously have been re-irradiated for overlapping second primary or relapse Other second primary tumors that are not under control Distant metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: FDG-PET guided dose painting|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants accomplishing FDG-PET guided radiotherapy for recurrent and second primary head and neck cancer. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control (at 6 months after inclusion) evaluated with PET/CT (according to RECIST). |  | 6 months | 
| Number of participants with adverse events. | Number of participants with toxicity using CTCAE v3.0. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose painting, 18F-FDG, Positron emission tomography, Radiotherapy