Chemoradiotherapy Clinical Trial
Official title:
Total Neoadjuvant Treatment Versus Conventional Neo-chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk Factors: a Multicenter Randomized Phase III Clinical Study.
Purpose:To compare the efficacy and the safety of total neoadjuvant chemotherapy + TME with
standard neoadjuvant concurrent chemoradiotherapy + TME + adjuvant chemotherapy for locally
advanced rectal cancer patients with high risk factors of recurrence.
Evaluation indexes: (1) the primary evaluation index: disease-free survival (disease free
survival, DFS); (2) the secondary evaluation indexes: pathological complete remission rate
(pCR), the 3 year overall survival (overall survival, OS); R0 dissection rate; distant
metastasis free survival (DMFS); local recurrence free survival rate (LRRFS); tumor
regression grade (TRG, tumor regression grade) and the adverse reaction rate during the
chemotherapy, the operation safety index; quality of life; psychological and cognitive
effects, assessment of nutritional status.
Safety evaluation indexes: including all adverse events observed during the experiment.
Number of patients: 458 cases Study design: patients will be randomly assigned into the total
neoadjuvant treatment group (experimental group, TNT) and neoadjuvant concurrent chemotherapy
group (control group, CRT) in the ratio of 1: 1. The patients of experimental group will be
given 1 cycle of induction CAPOX (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2, bid,
d1-14) prior to radiotherapy. Then pelvic IMRT/VMAT (50-50.4Gy/25-28f) and two cycles of
concurrent chemotherapy (Oxaliplatin 130mg/m2, d1, d 22, Capecitabine 825mg/m2, bid, 5d/w,
25-28d) are performed. And three cycles of consolidation chemotherapy (CAPOX) are delivered
after concurrent chemoradiotherapy. Total mesorectal excision (TME) is performed after
completion of the whole neoadjuvant treatment. The patients of control group will receive
standard concurrent neoadjuvant chemoradiotherapy with capecitabine (825mg/m2, bid, 5d/w)
followed by TME 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients are
treated with another 6 cycles of CAPOX.
Schedule: Investigators plan to finish the study in 4 years and write the related work within
2 years after the completion of this study.
n/a
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