title: Randomised controlled trial of temoporfin photodynamic therapy plus chemotherapy in nonresectable biliary carcinoma--PCS Nordic study.
abstract: BACKGROUND
  Photodynamic therapy (PDT) in combination with stent have shown promising results in the treatment of biliary tract cancer (BTC) in patients not suitable for surgery. Chemotherapy has been shown to improve survival in patients with local advanced and metastatic BTC.
  
  
  METHODS
  In the current randomized trial the combination of chemotherapy and stent with and without temoporfin (Foscan) photodynamic therapy (PDT), with a primary endpoint on feasibility and safety, has been performed. Ten patients in each group.
  
  
  RESULTS
  No serious, acute procedure-related complication related to PDT or the treatment combination was seen. The number of patients with cholangitis was equal in both groups. In the PDT group--arm A--two patients had cutaneous erythema after sun exposition, one of them with a localized blister. No neutropenic infection was seen. Quality of Life (QoL) was similar in both treatment groups. Progression free survival was numerically longer in the PDT group.
  
  
  CONCLUSIONS
  The treatment combination was feasible. There was no serious complication related to PDT or the treatment combination. Number of cholangitis was equal in both groups, two abscesses were observed in the PDT group. Progression free survival was numerically longer in the PDT group.
authors.affiliation: Dept. of Gastroenterology, Oslo University Hospital, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway. Electronic address: truls.hauge@medisin.uio.no.
authors.forename: T
authors.initials: T
authors.lastname: Hauge
authors.affiliation: Dept. of Oncology, Oslo University Hospital, Norway.
authors.forename: P W
authors.initials: PW
authors.lastname: Hauge
authors.affiliation: Dept. of Gastroenterology, Oslo University Hospital, Norway; Division of Cancer, Surgery and Transplantation, Oslo University Hospital, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Warloe
authors.affiliation: Dept. of Radiology and Nuclear Medicine, Oslo University Hospital, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Drolsum
authors.affiliation: Dept. of Radiology and Nuclear Medicine, Oslo University Hospital, Norway.
authors.forename: C
authors.initials: C
authors.lastname: Johansen
authors.affiliation: Dept. of Radiology and Nuclear Medicine, Oslo University Hospital, Norway.
authors.forename: E
authors.initials: E
authors.lastname: Viktil
authors.affiliation: Section of Gastroenterology, Oslo University Hospital, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.
authors.forename: L
authors.initials: L
authors.lastname: Aabakken
authors.affiliation: Division of Cancer, Surgery and Transplantation, Oslo University Hospital, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Buanes
authors.affiliation: Dept. of Gastroenterology, Oslo University Hospital, Norway.
authors.forename: Z
authors.initials: Z
authors.lastname: Konopski
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008652:Mesoporphyrins / Q000008:administration & dosage*; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage; D015607:Stents; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D008652:Mesoporphyrins; D017319:Photosensitizing Agents; C072269:temoporfin
keywords: Biliary tract cancer; ERCP; Feasibility and safety; Photodynamic therapy; Stent