title: The GOFURTGO Study: AGITG phase II study of fixed dose rate gemcitabine-oxaliplatin integrated with concomitant 5FU and 3-D conformal radiotherapy for the treatment of localised pancreatic cancer.
abstract: BACKGROUND
  Locally advanced inoperable pancreatic cancer (LAPC) has a poor prognosis. By increasing intensity of systemic therapy combined with an established safe chemoradiation technique, our intention was to enhance the outcomes of LAPC. In preparation for phase III evaluation, the feasibility and efficacy of our candidate regimen gemcitabine-oxaliplatin chemotherapy with sandwich 5-fluorouracil (5FU) and three-dimensional conformal radiotherapy (3DCRT) needs to be established.
  
  
  METHODS
  A total of 48 patients with inoperable LAPC without metastases were given gemcitabine (1000 mg m(-2) d1 + d15 q28) and oxaliplatin (100 mg m(-2) d2 + d16 q28) in induction (one cycle) and consolidation (three cycles), and 5FU 200 mg m(-2) per day over 6 weeks during 3DCRT 54 Gy.
  
  
  RESULTS
  Median duration of sustained local control (LC) was 15.8 months, progression-free survival (PFS) was 11.0 months, and overall survival was 15.7 months. Survival rates for 1, 2, and 3 years were 70.2%, 21.3%, and 12.8%, respectively. Global quality of life did not significantly decline from baseline during treatment, which was associated with modest treatment-related toxicity.
  
  
  CONCLUSIONS
  Fixed-dose gemcitabine and oxaliplatin, combined with an effective and safe regimen of 5FU and 3DCRT radiotherapy, was feasible and reasonably tolerated. The observed improved duration of LC and PFS with more intensive therapy over previous trials may be due to patient selection, but suggest that further evaluation in phase III trials is warranted.
authors: Department of Medical Oncology, Prince of Wales Hospital, High Street, Randwick, New South Wales 2031, Australia. david.goldstein@sesiahs.health.nsw.gov.au
authors: D
authors: D
authors: Goldstein
authors: N
authors: N
authors: Spry
authors: M M
authors: MM
authors: Cummins
authors: C
authors: C
authors: Brown
authors: G A
authors: GA
authors: van Hazel
authors: S
authors: S
authors: Carroll
authors: S
authors: S
authors: Selva-Nayagam
authors: M
authors: M
authors: Borg
authors: S P
authors: SP
authors: Ackland
authors: C
authors: C
authors: Wratten
authors: J
authors: J
authors: Shapiro
authors: I W T
authors: IW
authors: Porter
authors: G
authors: G
authors: Hruby
authors: L
authors: L
authors: Horvath
authors: S
authors: S
authors: Bydder
authors: C
authors: C
authors: Underhill
authors: J
authors: J
authors: Harvey
authors: V J
authors: VJ
authors: Gebski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D018395:CA-19-9 Antigen / Q000097:blood; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine