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More info
You can access this
clinical trial
if you have
Cancer, Colon Cancer, Colorectal Cancer, Fever, Locally Advanced, Metastatic Colorectal Cancer, Neutropenia or Rectal Cancer
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

Provided treatments

  • Drug: Pegfilgrastim
  • Drug: Placebo
  • Biological: Bevacizumab
  • Drug: Standard Chemotherapy
Tris trial is registered with FDA with number: NCT00911170. The sponsor of the trial is Amgen and it is looking for 847 volunteers for the current phase.
Official trial title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Admininstered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)