title: Randomized clinical trial on 7-days-a-week post-operative radiotherapy vs concurrent post-operative radiochemotherapy in locally advanced cancer of the oral cavity/oropharynx: a report on acute normal tissue reactions.
abstract: OBJECTIVE
  The purpose of the study was to evaluate acute normal tissue reactions and treatment compliance in a randomized clinical trial on 7-days-a-week post-operative radiotherapy (p-CAIR) vs post-operative concurrent radiochemotherapy (p-RTCT) in locally advanced cancer of the oral cavity/oropharynx. The sample analyzed at present represents approximately 30% of the intended future trial size.
  
  
  METHODS
  The patients were randomly assigned to receive 63 Gy in 1.8-Gy fractions 7 days a week (n = 44) or 63 Gy in 1.8-Gy fractions 5 days a week with concurrent cisplatin 80-100 mg per square metre of body surface area on Days 1, 22 and 43 of the course of radiotherapy (n = 40). Acute mucosal reactions were scored using the modified Dische system.
  
  
  RESULTS
  15 (17.9%) patients, including 5 patients in p-CAIR and 10 patients in p-RTCT, did not comply with the assigned radiation treatment, mostly because of rapid tumour progression or deteriorating general performance. In p-RTCT, 22 (55%) patients received less than the intended three courses of chemotherapy mostly owing to haematological toxicity. The average maximum mucosal severity score was 14.2 in p-CAIR compared with 13.4 in p-RTCT; the difference was not statistically significant (p = 0.31).
  
  
  CONCLUSIONS
  The schedules compared (p-CAIR and p-RTCT) did not differ considerably with respect to acute mucosal reactions. Haematological toxicity in p-RTCT was elevated compared with p-CAIR. Both schedules were considered tolerable with respect to acute toxicity, which justifies further recruitment to the trial.
  
  
  CONCLUSIONS
  The results show that early mucosal reactions are comparable in both trial arms but haematological toxicity is more pronounced during radiochemotherapy.
authors.affiliation: 1 Radiotherapy and Chemotherapy Clinic and Teaching Hospital, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Rafal
authors.initials: R
authors.lastname: Suwinski
authors.affiliation: 2 Department of Radiation Oncology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Wozniak
authors.affiliation: 3 Department of Laryngology, Silesian Medical University, Katowice, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Misiolek
authors.affiliation: 4 Department of Pathology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Jaworska
authors.affiliation: 5 Department of Medical Oncology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Kozaczka
authors.affiliation: 5 Department of Medical Oncology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Wieslaw
authors.initials: W
authors.lastname: Bal
authors.affiliation: 5 Department of Medical Oncology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Nowara
authors.affiliation: 2 Department of Radiation Oncology, Center of Oncology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Poland.
authors.forename: Leszek
authors.initials: L
authors.lastname: Miszczyk
mesh_terms: D000328:Adult; D000368:Aged; D059248:Chemoradiotherapy / Q000379:methods*; D019583:Dose Fractionation, Radiation; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth / Q000187:drug effects* / Q000528:radiation effects*; D009960:Oropharynx / Q000187:drug effects* / Q000528:radiation effects*; D011182:Postoperative Care / Q000379:methods; D011832:Radiation Injuries; D011879:Radiotherapy Dosage