title: Phase I-II study of hypofractionated simultaneous integrated boost with tomotherapy for prostate cancer.
abstract: OBJECTIVE
  To report planning and acute toxicity data of the first 60 patients treated within a Phase I-II study with moderate hypofractionation by image-guided helical tomotherapy.
  
  
  METHODS
  Various clinical target volumes (CTVs) were defined: CTV1-pelvic nodes; CTV2-upper portion of seminal vesicles; CTV3-lower portion of SV; CTV4-prostate; overlap between planning target volume (PTV) 4 and rectum. Different doses to each PTV were simultaneously delivered in 28 fractions. For 31 low-risk patients: 56.0, 61.6, and 71.4 Gy for PTV2-4, respectively; for 20 intermediate-risk patients: 51.8, 61.6, 65.5, and 74.2 Gy for PTV1-4, respectively; for 9 high-risk patients: 51.8 and 65.5 Gy for PTV1-2 and 74.2 Gy for PTV3-4. For all patients, the dose to overlap was 65.5 Gy.
  
  
  RESULTS
  The mean fraction of rectum receiving more than 65 Gy (V65) and rectal Dmax were 10% and 70.8 Gy respectively. In cases of pelvic node irradiation, the intestinal cavity (outside PTV) receiving > 45 and 50 Gy was 86 and 12 cc, respectively. A homogeneous dose distribution within each PTV was guaranteed. Acute genitourinary toxicity according to RTOG scoring system was as follows: 21/60 (35%) Grade 1, 12/60 (20%) Grade 2, 2/60 (3%) Grade 3. Acute rectal toxicities were: 18/60 (30%) Grade 1. Twelve (20%) patients showed Grade 1 upper intestinal toxicity (uGI). No patients experienced > or = Grade 2 acute rectal or uGI side effects.
  
  
  CONCLUSIONS
  This study shows excellent results with regard to acute toxicity. Further research is necessary to assess definitive late toxicity and tumor control outcome.
authors.affiliation: Department of Radiotherapy, Scientific Institute San Raffaele, Milan, Italy. dimuzio.nadia@hsr.it
authors.forename: Nadia
authors.initials: N
authors.lastname: Di Muzio
authors.forename: Claudio
authors.initials: C
authors.lastname: Fiorino
authors.forename: Cesare
authors.initials: C
authors.lastname: Cozzarini
authors.forename: Filippo
authors.initials: F
authors.lastname: Alongi
authors.forename: Sara
authors.initials: S
authors.lastname: Broggi
authors.forename: Paola
authors.initials: P
authors.lastname: Mangili
authors.forename: Giorgio
authors.initials: G
authors.lastname: Guazzoni
authors.forename: Riccardo
authors.initials: R
authors.lastname: Valdagni
authors.forename: Riccardo
authors.initials: R
authors.lastname: Calandrino
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Fazio
mesh_terms: D000368:Aged; D019583:Dose Fractionation, Radiation; D005270:Femur Head / Q000528:radiation effects; D006801:Humans; D015182:Lymphatic Irradiation; D008297:Male; D008875:Middle Aged; D010388:Pelvis; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000209:etiology*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods; D012007:Rectum / Q000528:radiation effects; D012669:Seminal Vesicles / Q000528:radiation effects; D001743:Urinary Bladder / Q000528:radiation effects