Table 1.

Summary of 9 Trial Proposals Reviewed by SWOG’s Executive Review Committee between 2009 and 2013 That Were Used to Develop Our VOI Analyses Processes

Proposal ID	Trial Proposal Title	Phase	Sample Size	Committee	Endpoint	Year Reviewed
A	Prospective Evaluation of the Benefit of a Standard Versus An Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Bladder Cancer With Adjuvant Chemotherapy Administration for Node-Positive Disease	III	630	Genitourinary	PFS	2010
B	A Phase III Randomized Trial Comparing LHRHa + TAK-700 With LHRHa + Bicalutamide in Patients With Newly Diagnosed D2 Prostate Cancer	III	1486	Genitourinary	OS	2011
C	A Randomized Phase II Pilot Study Prospectively Assigning Treatment for Patients Based on ERCC1 for Advanced/Metastatic Gastric Cancer or Gastroesophageal (GE) Junction Cancer	II	200	Gastrointestinal	PFS	2010
D	Randomized Phase II Clinical Trial of AZD-6244 and MK-2206 v. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy	II	120	Gastrointestinal	OS	2011
E	Randomized Phase II Study Comparing the Novel MEK Inhibitor, Trametinib, to Standard of Care Chemotherapy in Patients With KRAS Mutant Metastatic Colorectal Cancer	II	92	Gastrointestinal	PFS	2013
F	Exemestane v. a Combination of Exemestane and the Monoclonal Antibody IGF-1R Inhibitor IMC-A12 in Patients With Metastatic ER/PgR Positive Breast Cancer	III	690	Breast	PFS	2009
G	Capecitabine and Dasatinib as Adjuvant Therapy in Patients with HER-2/neu Negative Breast Cancer	III	720	Breast	RFS	2008
H	Adjuvant Endocrine Therapy +/− Everolimus in Patients With High-Risk, Node-Positive, Hormone Receptor Positive and HER2-neu Normal Breast Cancer	III	3400	Breast	RFS	2011
I	Intensive v. Less Intensive Dosing of Zoledronic Acid v. Denosumab as Adjuvant Therapy for Early Stage Breast Cancer	III	680	Breast	OS	2010

OS, overall survival; PFS, progression-free survival; RFS, recurrence-free survival.