CUP-ONE Cancer of unknown primary-1: An NCRN phase II study

• Research type

  Research Study

• Full title

  A multi-centre phase II trial to assess the efficacy of epirubicin, cisplatin and capecitabine (ECX) in cancers of unknown primary (CUP): incorporating the prospective validation of molecular classifiers in diagnosis and classification and exploratory metabonomics.

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Eudract number

  2008-000657-35

• ISRCTN Number

  Not submitted

• Research summary

  Metastatic Carcinomas (orcancers that have spread widely) from an Unknown Primary origin or site (CUP)make up 3-10% of all cancers and rank among the 'top ten' commonestmalignancies. However, it is a very poorly researched and understood area. Theycause much uncertainty and confusion for both patients and oncologists alike,as the primary origin is currently very difficult to confirm conclusively. Manypatients are treated eventually as "known primaries" for clinicalreasons, when there still remains diagnostic uncertainty. i.e treated on suspicion,rather than conclusively identified. The prognosis of CUP patients is poor, themedian survival is 8-12 months. Despite this, there are few clinical treatmentstudies, and therefore no consensus on investigations and treatment standardsin the UKor worldwide. With developments in modern clinical investigations, there is nowan opportunity to coordinate the largest clinical and translational trial anddatabase, which should allow possible identification of new markers ofclassification, prognosis and treatment responses. CUP-ONE is a multi-centresingle-arm phase II trial of epirubicin, cisplatin and capecitabine (ECX)incorporating the prospective validation of new techniquiques of molecularclassifiers and exploratory metabonomics. Four new laboratory tests notconfirmed in this way before, will be used on biopsy and patient samples tolocate the primary source of the tumour. The Treatment part of the trialconsists a single-arm phase II design, which aims to establish the efficacy ofthe ECX regimen, one of the commonest used regimens for CUP in the UK. Theassociation of the molecular signatures with patient outcome can thus beexplored. This pilot study should allow a more logical framework to beelucidated, both clinically and biologically, as to how highly metastaticcancers might be efficiently and economically investigated and managed in thefuture.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/61

• Date of REC Opinion

  8 Oct 2008

• REC opinion

  Further Information Favourable Opinion