NCT01540058

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neoplasms, Unknown Primary

Interventions

Type	Name	Description
OTHER	Cancer Type ID test	CancerTYPE ID is a real-time RT-PCR assay that measures and interprets the differential expression of 92 genes as a molecular correlate for tumor classification. The test classifies 28 main tumor types and 50 subtypes using an algorithm incorporating gene expression data from a reference database of 2,094 tumor specimens. CancerTYPE ID is used, in conjunction with other clinical and diagnostic procedures, to help identify tumor type and histological subtype. The performance characteristics and reproducibility of the test have been published previously (Erlander et al., 2011 ; Kerr et al., 2012). CancerTYPE ID is conducted on formalin-fixed paraffin-embedded (FFPE) tumor specimens at bioTheranostics' high complexity laboratory, which is certified by Clinical Laboratory Improvement Amendments (CLIA), accredited by the College of American Pathologists (CAP), and approved by the State of New York.
OTHER	No test Empiric strategy	Empiric strategy

Timeline

• Start date: 2012-03-22
• Primary completion: 2019-08-27
• Completion: 2019-08-27
• First posted: 2012-02-28
• Last updated: 2020-02-17

Locations

3 sites across 3 countries: Denmark, France, Netherlands