Sponsor study identifier
Secondary identifiers
OTHER · CSET number
interventional
243
3 countries
3
Study Start
March 22, 2012
Actual (reported)Primary Completion
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 27, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2012
Actual (reported)February 28, 2012
Actual (reported)March 22, 2012
Actual (reported)August 27, 2019
Actual (reported)August 27, 2019
Actual (reported)Progression free survival
Progression according to RECIST criteria or death of any cause.
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
Response rate
An expected average of 1 year
Tolerance (Toxicity grade III and IV, toxic death)
An expected average of 1 year
Overall survival
From the day of randomization to death or last date of follow-up, assessed up to 18 months
Treatment considered as the standard at the time of patient inclusion based on the primary cancer suspected by "the BioTheranostics Cancer Type ID test" molecular analysis
Gemcitabine/Cisplatin
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.
Rigshospitalet
Copenhagen, 2100, Denmark
Institut Gustave Roussy
Villejuif, Val De Marne, 94805, France
Viecuri Medical Centre Venlo
Venlo, 5912 BL, Netherlands
Karim FIZAZI, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
243 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2012
First Posted
February 28, 2012
Study Start
March 22, 2012
Actual (reported)Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
Empiric strategy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)Last Updated
February 17, 2020
Record last verified: 2020-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: