Evaluation of the study and its end points
tumor, Tumor, neutropenia, diarrhea, toxicity, febrile neutropenia, mucositis, Cancer
TUMOR, RECURRENCE, TUMOR, NEUTROPENIA, RESIDUAL TUMOR, POSTOPERATIVE COMPLICATIONS, FEBRILE NEUTROPENIA, DISEASE, SECONDARY, MUCOSITIS, REGRESSION, COMPLICATIONS, CANCER
The primary endpoint was the pCR rate, which was defined as the absence of tumor cells in both primary and local lymph nodes. The extent of residual tumor in the resected TME specimens were classified according to the TNM staging system of the American Joint Committee on Cancer version 7. In addition to TN staging, the pathological examination report also included the status of extramural venous invasion (EMVI) and CRM. Tumor regression was assessed by the DWORAK grading system [The secondary endpoints included the R0 resection and local recurrence rates, disease free survival (DFS), OS, safety of nCT and postoperative complications. Safety was evaluated by investigation according to the NCI CTC AE 4.0 guidelines. Dose reduction was allowed in cases of severe toxicity which was mainly manifested by grade 4 neutropenia or grade 3 febrile neutropenia, diarrhea, or mucositis. Prophylaxis with G-CSF is not recommended unless grade 4 neutropenia with febrile neutropenia occurred during the previous cycle of treatment. The incidence of complications within 1 month after surgery was recorded and evaluated according to the Clavien-Dindo grading system.