NRG-GY004 IMPORTANT INFORMATION

Ongoing review of data from NRG-GY004 has identified a small number of patients who received additional, non-protocol treatment for their ovarian cancer prior to documentation of disease progression.  As the primary endpoint of these trials is progression-free survival, initiation of non-protocol therapy prior to progression compromises the entire study, and is a major deviation from the protocol design.  This includes use of maintenance therapy (e.g., PARP inhibitor therapy, bevacizumab, radiation therapy) following treatment on the standard platinum-based chemotherapy arm.

Patients should NOT receive any subsequent therapy (including maintenance therapy) until progression by RECIST 1.1 is documented (see protocol section 5.1.1).

If patients have received non-protocol therapy prior to documented disease progression, please ensure that:

  • the non-protocol therapy is reported on the Non-Protocol Therapy Reporting Form - Follow Up form within 14 days, and
  • the violation is reported to the applicable IRB(s)
    • For NCI CIRB sites, please report the non-compliance violation to NRG Oncology by sending the following information to NRG-GY-Regulatory@nrgoncology.org:
      • NCI CTEP Institution Code
      • Institution Name
      • How many patient(s)
      • Date of event
    • For sites using their local IRB, please report this non-compliance violation, in accordance with your site’s IRB SOPs and guidelines, as soon as possible.  Please forward the IRB acknowledgment to NRG-GY-Regulatory@nrgoncology.org.

 

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