title: Induction chemotherapy with docetaxel/cisplatin/5-fluorouracil followed by randomization to two cisplatin-based concomitant chemoradiotherapy schedules in patients with locally advanced head and neck cancer (CONDOR study) (Dutch Head and Neck Society 08-01): A randomized phase II study.
abstract: OBJECTIVE
  To study the feasibility of induction chemotherapy added to concomitant cisplatin-based chemoradiotherapy (CRT) in patients with locally advanced head and neck cancer (LAHNC).
  
  
  METHODS
  LAHNC patients were treated with 4 courses of docetaxel/cisplatin/5-fluorouracil (TPF) followed by randomization to either cisplatin 100 mg/m(2) with conventional radiotherapy (cis100 + RT) or cisplatin 40 mg/m(2) weekly with accelerated radiotherapy (cis40 + ART). Primary endpoint was feasibility, defined as receiving ≥ 90% of the scheduled total radiation dose. Based on power analysis 70 patients were needed.
  
  
  RESULTS
  65 patients were enrolled. The data safety monitoring board advised to prematurely terminate the study, because only 22% and 41% (32% in total) of the patients treated with cis100 + RT (n = 27) and cis40 + ART (n = 29) could receive the planned dose cisplatin during CRT, respectively, even though the primary endpoint was reached. Most common grade 3-4 toxicity was febrile neutropenia (18%) during TPF and dehydration (26% vs 14%), dysphagia (26% vs 24%) and mucositis (22% vs 57%) during cis100 + RT and cis40 + ART, respectively. For the patients treated with cis100 + RT and cis40 + ART, two years progression free survival and overall survival were 70% and 78% versus 72% and 79%, respectively.
  
  
  CONCLUSIONS
  After TPF induction chemotherapy, cisplatin-containing CRT is not feasible in LAHNC patients, because the total planned cisplatin dose could only be administered in 32% of the patients due to toxicity. However, all but 2 patients received more than 90% of the planned radiotherapy. Clinical Trials Information: NCT00774319.
authors.affiliation: Departments of Medical Oncology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands. Electronic address: Chantal.Driessen@radboudumc.nl.
authors.forename: C M L
authors.initials: CM
authors.lastname: Driessen
authors.affiliation: Department of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: J P
authors.initials: JP
authors.lastname: de Boer
authors.affiliation: Departments of Medical Oncology, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Gelderblom
authors.affiliation: Department of Radiation Oncology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: C R N
authors.initials: CR
authors.lastname: Rasch
authors.affiliation: Department of Radiation Oncology, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: de Jong
authors.affiliation: Department of Radiology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands; Department of Radiology, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: B M
authors.initials: BM
authors.lastname: Verbist
authors.affiliation: Department of Medical Microbiology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands.
authors.forename: W J G
authors.initials: WJ
authors.lastname: Melchers
authors.affiliation: Department of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: M E T
authors.initials: ME
authors.lastname: Tesselaar
authors.affiliation: Departments of Medical Oncology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands; The institute of Cancer Research and the Royal Marsden NHS Foundation Trust, London, UK.
authors.forename: W T A
authors.initials: WT
authors.lastname: van der Graaf
authors.affiliation: Department of Radiation Oncology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands.
authors.forename: J H A M
authors.initials: JH
authors.lastname: Kaanders
authors.affiliation: Departments of Medical Oncology, Radboud University Medical Center Nijmegen, PO Box 9191, 6500 HB, Nijmegen, The Netherlands.
authors.forename: C M L
authors.initials: CM
authors.lastname: van Herpen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D057239:Early Termination of Clinical Trials; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009426:Netherlands; D011879:Radiotherapy Dosage; D012307:Risk Factors; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil
keywords: Chemoradiotherapy; Head and neck cancer; Induction chemotherapy; TPF