Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2015-06-30
2023-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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FDG-PET guided dose painting
Eligibility Criteria
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Inclusion Criteria
* 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 who previously have been re-irradiated for overlapping second primary or relapse
* Other second primary tumors that are not under control
* Distant metastatic disease
18 Years
ALL
No
Sponsors
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Norwegian Cancer Society
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Einar Dale
Senior Consultant
Principal Investigators
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Einar Dale, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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Skjotskift T, Evensen ME, Furre T, Moan JM, Amdal CD, Bogsrud TV, Malinen E, Dale E. Dose painting for re-irradiation of head and neck cancer. Acta Oncol. 2018 Dec;57(12):1693-1699. doi: 10.1080/0284186X.2018.1512753. Epub 2018 Oct 3.
Related Links
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Regional ethics committee
Other Identifiers
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2015/118
Identifier Type: -
Identifier Source: org_study_id