title: Phase II trial evaluating the feasibility of interdigitating folfox with chemoradiotherapy in locally advanced and metastatic rectal cancer.
abstract: BACKGROUND
  Patients (pts) with metastatic rectal cancer and symptomatic primary, require local and systemic control. Chemotherapy used during chemoradiotherapy (CRT) is adequate for radiosensitisation, but suboptimal for systemic control. The aim of this phase II study was to assess tolerability, local/systemic benefits, of a novel regimen delivering interdigitating intensive chemotherapy with radical CRT.
  
  
  METHODS
  Eligible pts had untreated synchronous symptomatic primary/metastatic rectal cancer. A total of 12 weeks of treatment with split-course pelvic CRT (total 50.4 Gy with concurrent oxaliplatin and 5-FU infusion) alternating with FOLFOX chemotherapy. All pts staged with CT, MRI and FDG-PET pre and post treatment.
  
  
  RESULTS
  Twenty-six pts were treated. Rectal primary MRI stage: T3 81% and T4 15%. Liver metastases in 81%. Twenty-four pts (92%) completed the 12-week regimen. All patients received planned RT dose, and for both agents over 88% of patients achieved a relative dose intensity of >75%. Grade 3 toxicities: neutropenia 23%, diarrhoea 15%, and radiation skin reaction 12%. Grade 4 toxicity: neutropenia 15%. FDG-PET metabolic response rate for rectal primary 96%, and for metastatic disease 60%.
  
  
  CONCLUSIONS
  Delivery of interdigitating chemotherapy with radical CRT was feasible to treat both primary and metastatic rectal cancer. High completion and response rates were encouraging.
authors.affiliation: 1] Division of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia [2] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Michael
authors.affiliation: Division of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Chander
authors.affiliation: Department of Medical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.
authors.forename: J
authors.initials: J
authors.lastname: McKendrick
authors.affiliation: Division of Surgical Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: J R
authors.initials: JR
authors.lastname: MacKay
authors.affiliation: Department of Surgery, Box Hill Hospital, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Steel
authors.affiliation: 1] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia [2] Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Hicks
authors.affiliation: Division of Surgical Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Heriot
authors.affiliation: Division of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: T
authors.initials: T
authors.lastname: Leong
authors.affiliation: Department of Medical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Cooray
authors.affiliation: 1] Division of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia [2] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Jefford
authors.affiliation: Division of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Zalcberg
authors.affiliation: Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Bressel
authors.affiliation: Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: B
authors.initials: B
authors.lastname: McClure
authors.affiliation: Division of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: S Y
authors.initials: SY
authors.lastname: Ngan
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D015331:Cohort Studies; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D008175:Lung Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010386:Pelvic Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D011379:Prognosis; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil