title: Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 × 5 Gy) and intraoperative radiation therapy (15 Gy) in patients with primarily resectable pancreatic cancer - NEOPANC.
abstract: BACKGROUND
  The current standard treatment, at least in Europe, for patients with primarily resectable tumors, consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Postoperative chemoradiation has shown improved local control and overalls survival compared to surgery alone but the value of additional radiation has been questioned in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition of radiation therapy considering the high rates of microscopically incomplete resections after surgery. As postoperative administration of radiation therapy has some general disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose escalation, reduction of toxicity and patients comfort especially if hypofractionated regimens with highly conformal techniques like intensity-modulated radiation therapy are considered.
  
  
  METHODS
  The NEOPANC trial is a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant short course intensity-modulated radiation therapy (5 × 5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy), followed by adjuvant chemotherapy according to the german treatment guidelines, in patients with primarily resectable pancreatic cancer. The aim of accrual is 46 patients.
  
  
  CONCLUSIONS
  The primary objectives of the NEOPANC trial are to evaluate the general feasibility of this approach and the local recurrence rate after one year. Secondary endpoints are progression-free survival, overall survival, acute and late toxicity, postoperative morbidity and mortality and quality of life.
  
  
  BACKGROUND
  NCT01372735.
authors.affiliation: Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany. F.Roeder@dkfz.de.
authors.forename: Falk
authors.initials: F
authors.lastname: Roeder
authors.forename: Carmen
authors.initials: C
authors.lastname: Timke
authors.forename: Ladan
authors.initials: L
authors.lastname: Saleh-Ebrahimi
authors.forename: Lutz
authors.initials: L
authors.lastname: Schneider
authors.forename: Thilo
authors.initials: T
authors.lastname: Hackert
authors.forename: Werner
authors.initials: W
authors.lastname: Hartwig
authors.forename: Annette
authors.initials: A
authors.lastname: Kopp-Schneider
authors.forename: Frank W
authors.initials: FW
authors.lastname: Hensley
authors.forename: Markus W
authors.initials: MW
authors.lastname: Buechler
authors.forename: Juergen
authors.initials: J
authors.lastname: Debus
authors.forename: Peter E
authors.initials: PE
authors.lastname: Huber
authors.forename: Jens
authors.initials: J
authors.lastname: Werner
mesh_terms: D000230:Adenocarcinoma / Q000453:epidemiology / Q000532:radiotherapy* / Q000601:surgery; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007432:Intraoperative Period; D020360:Neoadjuvant Therapy / Q000379:methods; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D010190:Pancreatic Neoplasms / Q000453:epidemiology / Q000532:radiotherapy* / Q000601:surgery; D011446:Prospective Studies; D011829:Radiation Dosage; D050397:Radiotherapy, Intensity-Modulated; D016019:Survival Analysis