title: Randomized phase III trial (GORTEC 98-03) comparing re-irradiation plus chemotherapy versus methotrexate in patients with recurrent or a second primary head and neck squamous cell carcinoma, treated with a palliative intent.
abstract: OBJECTIVE
  This randomized phase III trial investigated the potential benefit of concurrent re-irradiation, fluorouracil and hydroxyurea versus methotrexate for patients treated with palliative intent for recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in previously irradiated area.
  
  
  METHODS
  Patients with recurrent HNSCC or a second primary not amenable to curative-intent treatment were randomized to the R-RT arm (concurrent re-irradiation, fluorouracil and hydroxyurea) or to the Ch-T arm (methotrexate). The primary endpoint was overall survival (OS). Due to a very slow accrual, the trial was closed after inclusion of 57 patients.
  
  
  RESULTS
  Fifty-seven patients were included. All patients died in the two arms with a maximal follow-up of 5years. Although four complete responses were achieved in R-RT arm, (none in Ch-T arm) re-irradiation did not improve OS compared with methotrexate (23% versus 22% at 1year, NS). Sixteen patients experienced clinical grade ⩾3 late toxicities (>6months), 11 in R-RT arm and five in Ch-T arm.
  
  
  CONCLUSIONS
  Premature discontinuation of the trial did not allow us to draw firm conclusions. However, there was no suggestion that concurrent re-irradiation, fluorouracil and hydroxyurea improved OS compared to methotrexate alone in patients treated with palliative intent for a recurrent or second primary HNSCC.
authors: Centre Jean Perrin, Clermont-Ferrand, France.
authors: Jacques
authors: J
authors: Tortochaux
authors: Yungan
authors: Y
authors: Tao
authors: Elodie
authors: E
authors: Tournay
authors: Michel
authors: M
authors: Lapeyre
authors: Francois
authors: F
authors: Lesaunier
authors: Etienne
authors: E
authors: Bardet
authors: François
authors: F
authors: Janot
authors: Antoine
authors: A
authors: Lusinchi
authors: Ellen
authors: E
authors: Benhamou
authors: Patrick
authors: P
authors: Bontemps
authors: Philippe
authors: P
authors: Maingon
authors: Gilles
authors: G
authors: Calais
authors: Nicolas
authors: N
authors: Daly-Schveitzer
authors: Pierre
authors: P
authors: Verrelle
authors: Jean
authors: J
authors: Bourhis
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D002423:Cause of Death; D059248:Chemoradiotherapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy*; D016609:Neoplasms, Second Primary / Q000628:therapy*; D010166:Palliative Care; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D008727:Methotrexate