Preliminary phase II results of selinexor, an oral selective inhibitor of nuclear export in patients with heavily pretreated gynecological cancers

Ignace Vergote, Bente Lund, Hanne Havsteen, Zaza Ujmajuridze, Karin Leunen, Charlotte Aaquist Haslund, Trine Juhler-Nøttrup, Henrik Roed, Tami Rashal, Anne L Kranich, Yosef Landesman, Jean-Richard Saint-Martin, Robert Carlson, Sharon Shacham, Michael Kauffman, Mansoor Raza Mirza

Research output: Contribution to journalConference abstract in journalResearchpeer-review

Abstract

BACKGROUND: There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer (CRC). A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease. We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival.

METHODS/DESIGN: The CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group (DCCG). Patients with synchronous unresectable metastases of CRC and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only, and resection of the primary tumour followed by systemic therapy. Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab. The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control arm.

DISCUSSION: The CAIRO4 study is a multicentre, randomized, phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC.

TRIAL REGISTRATION: The CAIRO4 study is registered at clinicaltrials.gov (NCT01606098).

Original languageEnglish
Article numberTPS5565
JournalJournal of Clinical Oncology
Volume33
Issue number15 Suppl.
ISSN0732-183X
Publication statusPublished - 2015
EventASCO Annual Meeting 2015 - Chicago, United States
Duration: 29 May 20152 Jun 2015

Conference

ConferenceASCO Annual Meeting 2015
CountryUnited States
CityChicago
Period29/05/201502/06/2015

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