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A Phase II Randomised, Double-blind, Placebo-controlled, Multicentre Comparative study of ZD1839 250 mg or 500 mg (Iressatm) given either continuously or concomitantly with cisplatin plus radiotherapy...

Update Il y a 4 ans
Reference: EUCTR2004-000358-21

A Phase II Randomised, Double-blind, Placebo-controlled, Multicentre Comparative study of ZD1839 250 mg or 500 mg (Iressatm) given either continuously or concomitantly with cisplatin plus radiotherapy for the treatment of patients with previously untreated unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma

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Extract

The primary objective of the study is to assess the additive effect of ZD1839 250 mg and ZD1839 500 mg (given either concomitantly or as maintenance) over cisplatin plus radiotherapy (RT) in terms of local disease control (progression-free) rate at 2 years.

Inclusion criteria

  • Untreated, unresected late stage III/IV non-metastatic head and neck squamous cell carcinoma

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