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Accrual barriers to S1314 COXEN Trial lowered


  [Jul. 8, 2015]
The S1314 COXEN trial for pre-operative bladder cancer patients has been amended to reduce barriers to activation and enrollment. Please reconsider the study at your site.

Based on SWOG member feedback, we have:

  • Removed the requirement that urologists must have performed at least 50 cystectomies in the last 3 years to participate in COXEN.
  • Removed the requirement that tissue blocks be submitted; instead, institutions now can send tissue slides.
  • Widened the allowable window for screening tests, clarified urine sample processing, and increased latitude for chemotherapy administration.

The COXEN neoadjuvant bladder study (S1314) is testing whether the COXEN gene expression model can predict the best chemotherapy treatment for patients based on individual tumor characteristics. This protocol randomizes T2-T4aN0M0 bladder cancer patients preoperatively to Gem-Cis versus MVAC chemotherapy. The primary endpoint is the pT0 rate, and trial investigators will examine the COXEN prognostic and predictive performance in this regard.

The COXEN trial will enroll 184 bladder cancer patients planning for cystectomy. If your institution has not opened S1314, please consider this study in light of these amendment changes. For questions, contact S1314 Principal Investigator Dr. Thomas Flaig at Thomas.Flaig@ucdcenver.edu or (303) 724-0499.

 

SWOG/Hope fund will support role of VAs in NCTN trials


  [Nov. 11, 2014]
<h4>SWOG/Hope fund will support role of VAs in NCTN trials</h4> SWOG-VA integration support will address the needs of VA medical centers that have been challenged by participation in NCI cooperative group (and now NCTN) cancer clinical trials for a variety of reasons, including lack of adequate institutional support and staffing for the conduct of studies and recruitment of veterans. These funds from The Hope Foundation will allow a select group of VA medical centers or small consortia to apply for one-time startup funds to increase access to cooperative group/NCTN trials within the VA system. Support may be used to assist sites in joining SWOG, in developing local procedures, in enrolling to the NCI Central IRB, or to cover salary for a specified cooperative group/NCTN on-site coordinator.

The Request for Applications (RFA) for these $25,000 awards will be posted soon. Please check back here at swog.org or check The Hope Foundation website at thehopefoundation.org.

 
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