Clinical Trial: Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Phase III Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With Carcinoma of an Unknown Primary (CUP)

Brief Summary: This is a european randomised, phase III, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. The purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (CUP).

Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: Progression free survival [ Time Frame: From date of randomization until the date of first progression or date of death from any cause, whichever came first, assessed up to 18 months ]

Progression according to RECIST criteria or death of any cause.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate [ Time Frame: An expected average of 1 year ]
    Response will be assessed using RECIST criteria
  • Tolerance (Toxicity grade III and IV, toxic death) [ Time Frame: An expected average of 1 year ]
    Toxicity will be assessed using NCI-CTC criteria version 4.0
  • Overall survival [ Time Frame: From the day of randomization to death or last date of follow-up, assessed up to 18 months ]
    Death of any cause


Original Secondary Outcome: Same as current

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: February 13, 2012
Date Started: March 2012
Date Completion: October 2017
Last Updated: February 9, 2016
Last Verified: February 2016