Phase 1 trial of preoperative, short-course carbon-ion radiotherapy for patients with resectable pancreatic cancer

Cancer. 2013 Jan 1;119(1):45-51. doi: 10.1002/cncr.27723. Epub 2012 Jun 28.

Abstract

Background: The authors evaluated the tolerance and efficacy of carbon-ion radiotherapy (CIRT) as a short-course, preoperative treatment and determined the recommended dose needed to reduce the risk of postoperative local recurrence without excess injury to normal tissue.

Methods: Patients radiographically defined with potentially resectable pancreatic cancer were eligible. A preoperative, short-course, dose-escalation study was performed with fixed 8 fractions in 2 weeks. The dose of irradiation was increased by 5% increments from 30 grays equivalents (GyE) to 36.8 GyE. Surgery was to be performed 2 to 4 weeks after the completion of CIRT.

Results: The study enrolled 26 patients. At the time of restaging after CIRT, disease progression with distant metastasis or refusal ruled out 5 patients from surgery. Twenty-one of 26 patients (81%) patients underwent surgery. The pattern of initial disease progression was distant metastasis in 17 patients (65%) and regional recurrence in 2 patients (8%). No patients experienced local recurrence. The 5-year survival rates for all 26 patients and for those who underwent surgery were 42% and 52%, respectively.

Conclusions: Preoperative, short-course CIRT followed by surgery is feasible and tolerable without unacceptable morbidity.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Female
  • Heavy Ion Radiotherapy* / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy / methods*
  • Neoplasm Recurrence, Local / prevention & control
  • Pancreatic Neoplasms / pathology
  • Pancreatic Neoplasms / radiotherapy*
  • Pancreatic Neoplasms / surgery
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant / methods
  • Survival Rate