title: Maximum tolerated dose in a phase I trial on adaptive dose painting by numbers for head and neck cancer.
abstract: OBJECTIVE
  To determine the maximum tolerated dose (MTD) in a phase I trial on adaptive dose-painting-by-numbers (DPBN) for non-metastatic head and neck cancer.
  
  
  METHODS
  Adaptive intensity-modulated radiotherapy was based on voxel intensity of pre-treatment and per-treatment [(18)F]fluoro-2-deoxy-d-glucose positron emission tomography ((18)F-FDG-PET) scans. Dose was escalated to a median total dose of 80.9 Gy in the high-dose clinical target volume (dose level I) and 85.9 Gy in the gross tumor volume (dose level II). The MTD would be reached, if ≥ 33% of patients developed any grade ≥ 4 toxicity (DLT) up to 3 months follow-up.
  
  
  RESULTS
  Between February 2007 and August 2009, seven patients at dose level I and 14 at dose level II were treated. All patients completed treatment without interruption. At a median follow-up for surviving patients of 38 (dose level I) and 22 months (dose level II) there was no grade ≥ 4 toxicity during treatment and follow-up but six cases of mucosal ulcers at latency of 4-10 months, of which five (36%) were observed at dose level II. Mucosal ulcers healed spontaneously in four patients.
  
  
  CONCLUSIONS
  Considering late mucosal ulcers as DLT, the MTD of a median dose of 80.9 Gy has been reached in our trial.
authors: Department of Radiotherapy, Ghent University Hospital, Belgium.
authors: Indira
authors: I
authors: Madani
authors: Fréderic
authors: F
authors: Duprez
authors: Tom
authors: T
authors: Boterberg
authors: Christophe
authors: C
authors: Van de Wiele
authors: Katrien
authors: K
authors: Bonte
authors: Philippe
authors: P
authors: Deron
authors: Werner
authors: W
authors: De Gersem
authors: Marc
authors: M
authors: Coghe
authors: Wilfried
authors: W
authors: De Neve
mesh_terms: D000368:Aged; D005260:Female; D019788:Fluorodeoxyglucose F18; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D049268:Positron-Emission Tomography; D011879:Radiotherapy Dosage; D061089:Radiotherapy, Image-Guided / Q000379:methods*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*
chemical_list: D019788:Fluorodeoxyglucose F18