title: A phase I/II study of altered fractionated IMRT alone for intermediate T-stage oropharyngeal carcinoma.
abstract: OBJECTIVE
  To prospectively assess the feasibility and efficacy of an accelerated and hyperfractionated intensity- modulated radiation therapy (IMRT) schedule for intermediate T-stage oropharyngeal cancer.
  
  
  METHODS
  Patients with T3 or unfavorable T2 oropharyngeal squamous cell carcinoma were eligible; a three-dose level simultaneous integrated boost IMRT strategy was used, delivering 78, 69, and 60 Gy to gross disease, high-risk and low-risk target areas, respectively, in 60 twice daily fractions over 6 weeks. No sequential/concomitant systemic treatment or up-front radical surgery was allowed. Median follow-up is 41.7 months (range: 3.5-80.8 months).
  
  
  RESULTS
  25 patients were treated from 11/2002 to 11/2005. 92% of the individual fractions were delivered as scheduled. Grade 3 mucosal and skin toxicity was 100% and 72%, respectively, none of which persisted beyond 12 weeks; a percutaneous endoscopic gastrostomy tube was temporarily placed in 60% of patients. The estimated locoregional progression-free, distant metastases-free, and overall survival rates at 3 years were 86.3% ± 7.4%, 76.4% ± 9.6%, and 70.0% ± 9.6%, respectively. At the same time interval, the actuarial prevalence of grade 3+ CTCAE v3.0 toxicity was 26.1%.
  
  
  CONCLUSIONS
  While the routine clinical use of this exploratory schedule is discouraged, it may represent the basis for future developments.
authors.affiliation: Department of Radiation Oncology, University of Texas Medical Branch, Galveston, TX 77030, USA. gbgunn@mdanderson.org
authors.forename: G Brandon
authors.initials: GB
authors.lastname: Gunn
authors.forename: Eugene J
authors.initials: EJ
authors.lastname: Endres
authors.forename: Brent
authors.initials: B
authors.lastname: Parker
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Sormani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sanguineti
mesh_terms: D005240:Feasibility Studies; D005774:Gastrostomy; D006801:Humans; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods*; D012867:Skin / Q000473:pathology / Q000528:radiation effects; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
references.citation: Strahlenther Onkol. 2008 Aug;184(8):400-5
references.pmid: 18956516
references.citation: Semin Radiat Oncol. 2004 Apr;14(2):110-20
references.pmid: 15095257
references.citation: Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):966-74
references.pmid: 17145527
references.citation: Lancet. 2003 Sep 20;362(9388):933-40
references.pmid: 14511925
references.citation: Strahlenther Onkol. 2007 Aug;183(8):417-23; discussion 424-5
references.pmid: 17680220
references.citation: Semin Radiat Oncol. 2004 Apr;14(2):103-9
references.pmid: 15095256
references.citation: Strahlenther Onkol. 2006 May;182(5):283-8
references.pmid: 16673062
references.citation: Clin Oncol (R Coll Radiol). 2007 Feb;19(1):8-22
references.pmid: 17305251
references.citation: J Clin Oncol. 2004 Jan 1;22(1):69-76
references.pmid: 14657228
references.citation: Int J Radiat Oncol Biol Phys. 2000 Feb 1;46(3):619-30
references.pmid: 10701741
references.citation: Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):374-87
references.pmid: 15380569
references.citation: Int J Radiat Oncol Biol Phys. 2007 Jul 1;68(3):741-9
references.pmid: 17398024
references.citation: Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6
references.pmid: 7713792
references.citation: Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1480-91
references.pmid: 14630288
references.citation: Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):396-402
references.pmid: 17321069
references.citation: Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1148-50
references.pmid: 11958923
references.citation: Phys Med Biol. 2004 Nov 7;49(21):4919-28
references.pmid: 15584527
references.citation: Strahlenther Onkol. 2003 Jun;179(6):390-5
references.pmid: 12789465
references.citation: Strahlenther Onkol. 2008 Jan;184(1):8-14
references.pmid: 18188517
references.citation: Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):1-3
references.pmid: 12007933
references.citation: Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1531-4
references.pmid: 7635798
references.citation: Head Neck. 2008 Aug;30(8):1090-8
references.pmid: 18528904
references.citation: Int J Radiat Oncol Biol Phys. 2004 May 1;59(1):43-50
references.pmid: 15093897
references.citation: Cancer. 2001 Dec 1;92(11):2856-67
references.pmid: 11753959
references.citation: Strahlenther Onkol. 2009 Jul;185(7):453-9
references.pmid: 19714307
references.citation: Int J Radiat Oncol Biol Phys. 1997 Aug 1;39(1):127-35
references.pmid: 9300747
references.citation: J Natl Cancer Inst. 2008 Feb 20;100(4):261-9
references.pmid: 18270337
references.citation: Lancet. 2006 Sep 2;368(9538):843-54
references.pmid: 16950362
references.citation: Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):931-8
references.pmid: 17011465
references.citation: Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):737-46
references.pmid: 18486356
references.citation: Int J Radiat Biol. 1998 Apr;73(4):395-9
references.pmid: 9587077
references.citation: Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):363-73
references.pmid: 15925451
references.citation: J Clin Oncol. 2008 Jul 20;26(21):3582-9
references.pmid: 18559875
references.citation: World J Surg. 2003 Jul;27(7):832-7
references.pmid: 14509515
references.citation: Am J Clin Oncol. 2006 Dec;29(6):606-12
references.pmid: 17148999
references.citation: Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1349-51
references.pmid: 7755796
references.citation: Semin Radiat Oncol. 2004 Apr;14(2):153-66
references.pmid: 15095261
references.citation: Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):438-44
references.pmid: 17141972
references.citation: Int J Radiat Oncol Biol Phys. 1994 Jul 30;29(5):1183-6
references.pmid: 7521864
references.citation: Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16
references.pmid: 10924966
references.citation: Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):93-8
references.pmid: 12504040
references.citation: Radiother Oncol. 1992 Dec;25(4):231-41
references.pmid: 1480768
references.citation: Stat Med. 1991 Mar;10(3):413-21
references.pmid: 2028125
references.citation: N Engl J Med. 2006 Feb 9;354(6):567-78
references.pmid: 16467544
references.citation: Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):630-7
references.pmid: 12062606
references.citation: Strahlenther Onkol. 2008 Feb;184(2):105-10
references.pmid: 18259703