title: Effect of total dose and fraction size on survival of patients with locally recurrent nasopharyngeal carcinoma treated with intensity-modulated radiotherapy: a phase 2, single-center, randomized controlled trial.
abstract: BACKGROUND
  The optimal model of total dose and fraction size for patients with locally recurrent nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT) remains unclear. The authors designed a randomized phase 2 clinical trial to investigate the efficacy of 2 different models, with the objective of determining an optimal model.
  
  
  METHODS
  Between January 2003 and December 2007, a total of 117 patients with locally recurrent nonmetastatic nasopharyngeal carcinoma were randomized to 2 different models of total dose and fraction size: group A (59 patients) received 60 gray in 27 fractions and group B (58 patients) received 68 gray in 34 fractions. Both groups received 5 daily fractions per week. All patients received IMRT alone.
  
  
  RESULTS
  The median follow-up was 25.0 months. The 5-year overall survival in group A was higher than that in group B (44.2% vs 30.3%; P =.06), and the local failure-free survival in group A was slightly lower than that in group B (63.7% vs 71.0%; P =.41). Severe late complications were the main cause of death. The incidences of mucosal necrosis and massive hemorrhage in patients in group B were significantly higher than those among patients in group A at 50.8% versus 28.8% (P =.02) and 31.0% versus 18.6% (P =.12), respectively. Tumor volume (P<.01) and model of total dose and fraction size (P =.03) were found to be significant factors for mucosal necrosis and massive hemorrhage.
  
  
  CONCLUSIONS
  Appropriately decreasing the total dose and increasing the fraction size can achieve local control similar to that achieved with a higher dose after IMRT; furthermore, it can improve overall survival by significantly reducing the incidence of severe late complications including mucosal necrosis and massive hemorrhage.
authors: Department of Radiation Oncology, Hui Zhou Municipal Centre Hospital, China.
authors: Yun-Ming
authors: YM
authors: Tian
authors: Chong
authors: C
authors: Zhao
authors: Ying
authors: Y
authors: Guo
authors: Ying
authors: Y
authors: Huang
authors: Shao-Min
authors: SM
authors: Huang
authors: Xiao-Wu
authors: XW
authors: Deng
authors: Cheng-Guang
authors: CG
authors: Lin
authors: Tai-Xiang
authors: TX
authors: Lu
authors: Fei
authors: F
authors: Han
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma; D002423:Cause of Death; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects; D017211:Treatment Failure; D047368:Tumor Burden
keywords: fraction size; intensity-modulated radiotherapy (IMRT); late complications; local recurrence; nasopharyngeal carcinoma; total dose