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A Randomized Phase 3 Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Monotherapy in Patients With Recurrent or Metastatic Head and Neck Cancer
Provider Data DescriptionThe objectives of the study are to compare the following between Arms.
The primary efficacy measure is OS.
Secondary endpoints include PFS, ORR, and DoR; time to worsening (TTW)
in dimensions of health-related quality of life (HRQoL) using FACT-H&N,
change from baseline in dimensions of HRQoL using FACT-H&N, and
Data ProviderEli Lilly
Partial set or SubsetOriginal Data
Patients in dataset795
# of Patients Control397
# of Patients ExperimentalN/A
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThis study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
Region(s)United States Argentina Belgium Brazil China Denmark France Germany Hungary India Italy Korea, Republic of Mexico Netherlands Poland Puerto Rico Romania Russian Federation South Africa Spain Taiwan