A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at
an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I)
phase study. The estimated duration of treatment was to be 6 months. Treatment was to be
administered up to progression, unacceptable toxicities, or withdrawal of consent. The
reason and date of removal of all participants was documented on the case report form.
Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or
withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until
documented progression or further anti-tumor therapy. Then, they would be followed every 3
months after progression for survival status; date of death or progression were reported.
Participants who ended treatment for progression, were to be followed every 3 months until
death. Date of death was reported. The planned duration of the study was 30 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.
every 8 weeks up to a maximum of 36 months
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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