Table 5. Non-randomized phase II trials utilizing selective surgery.
Reference; [Study interval] | Patients | N | Histology | Endpoints | Results |
---|---|---|---|---|---|
Wilson and Lim; [1993-1996] (31) | T1-3, N0-1, M0 | 32 | SCCA/ACA | Path response, survival, organ preservation, toxicity | Endoscopic response 77%, selective approach was feasible |
Ariga et al.; [2001-2005] (32) | T1-3, N0-1, M0 | 99 | SCCA | OS, DFS, QOL, toxicity | 26% cross-over to salvage surgery |
Swisher et al.; [2003-2006] (33) | T1-3, N0-1, M0-1a | 41 | SCCA/ACA | Treatment response, organ preservation, toxicity, feasibility | 1-yr survival goals not met, but feasibility demonstrated |
SCCA, squamous cell carcinoma; ACA, adenocarcinoma; OS, overall survival; DFS, disease free survival; QOL, quality of life.