About the NCIC Clinical Trials Group at Queen's University The NCIC Clinical Trials Group (NCIC CTG
) is a cancer clinical trials cooperative group that conducts Phase I-III trials testing anti-cancer and supportive therapies across Canada and internationally.
The NCIC CTG CO.17 trial was a randomized, multicenter, open-label phase 3 study of single-agent cetuximab combined with BSC versus BSC alone in patients with previously treated EGFR-positive mCRC.
We report here on the outcome of testing of NCIC CTG CO.17 patient tumor samples for KRAS mutation status with the therascreen KRAS kit to determine the clinical utility of the kit.
The trial design and eligibility criteria of the phase 3 NCIC CTG CO.17 trial have been reported previously.
The analysis of the NCIC CTG CO.17 study, using KRAS status determined by the QIAGEN therascreen KRAS kit, demonstrated a statistically significant improvement in OS for cetuximab plus BSC over BSC alone treatment within the KRAS wild-type subgroup (P = .002), whereas no meaningful differences were observed between treatment arms in the KRAS mutant subgroup (P = .55).
Because only 79% of the NCIC CTG CO.17 population was evaluable by the therascreen KRAS kit, several sensitivity analyses were performed to evaluate the impact of missing KRAS status.
These networks, like NCIC CTG, are connected at an international level so that results can be obtained in a more timely manner, are generalizable to a wider scope of patients, and so that trial costs are mutually leveraged.[sup.10] Collaborations between academic networks and industry may produce trials of higher quality than possible by either entity alone, including addressing correlative translational research questions, quality of life and economic analyses.
The NCIC CTG has operated within this evolving environment since 1980.
Recently activated trials through the NCIC CTG test drug, radiation and surgically-related strategies.
Within this context, NCIC CTG requires careful programmatic and project-specific business plans.
The NCIC CTG's Genitourinary Committee has experienced the highs and lows associated with successful completion of landmark trials and the realities of the current environment.
This effect was seen in 3 high-profile Canadian-led prostate cancer RCTs that failed or are struggling to reach their accrual goals: (1) NCIC CTG
's PR 10 study (SPIRIT: prostactectomy vs.