SWOG Study S1314 Page
This page is for reference and assistance to study sites participating in SWOG's clinical trial S1314, "A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer."
Why is this study being done?
The primary focus of this study is to see if looking at tumor biomarkers using a program called "coexpression extrapolation or COXEN" may predict a patient's response to chemotherapy before surgery. The COXEN program will not select the therapy, but the type of chemotherapy that the patients receive will be randomly decided. Information will be gathered and afer completion of the study, researchers will look at this information and outcomes for all study participants to see how COXEN relates to how participants responded to chemotherapy. Other potential tests to predict a patient's response to chemotherapy will also be evaluated.
In this study, patients will receive the treatment in Arm 1 (gemcitabine and cisplatin) or the treatment in Arm 2 [methotrexate, vinblastine, doxorubicin, cisplatin, and filgrastim (or pegfilgrastim)]. There will be about 184 people taking part in this study (92 in each arm).
More information about the study?
- Members version of the protocol abstract page (from which the full protocol is available): S1314 Protocol Abstract Page. Staff from non-SWOG sites can find the full protocol and related materials by logging in to the CTSU site.
- For general questions about the study, select "Protocols" as the subject area on the Contact Us page and we will get in touch with you.
- Participants can find a more comprehensive list of locations, including non-SWOG locations, where this trial is open in the "Contacts and Locations" section of ClinicalTrials.gov S1314 page.
Study Promotional Materials
S1314 Informational Slides: Use these slides to promote the study at your institution such as for in-services or meeting with Urologists.
S1314 Frequently Asked Questions: This document is for staff use only.
Bladder Cancer Advocacy: If you would like to role play how to present this study, would like advice on handling patient questions or how to work with local advocacy organizations, contact the SWOG Patient Advocates Committee Chair, Rick Bangs, at purmevpx/ng/zvaqfcevat/qbg/pbz, who is a bladder cancer survivor.
Recruitment Questions: If you would like advice on patient recruitment materials or strategies, contact Karen Anderson, SWOG Recruitment Manager at wraavsrez/ng/peno/qbg/bet or 206-652-1325.
Study Questions: For study related questions, please contact F1314dhrfgvba/ng/fjbt/qbg/bet.