To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.
Neoadjuvant Chemotherapy alone has showed much benefit for low/ intermediate risk stage II/III rectal cancer which would be verified by the PROSPECT trial. However, the effect of the Neoadjuvant chemotherapy was heterogeneous in different patients. It's important to verify those chemo-resistant cases as early as possible. So that, this trial will compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer to explore whether those chemotherapeutic non-responders after 2 cycles Capox was non-inferior to those after 4 cycles chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
554
oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals
Genecast Biotechnology Co., Ltd
Wuxi, Jiangsu, China
the Third People'S Hospital of Chengdu
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
The Third Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
pathological Tumor Regression Grade evaluation
pTRG
Time frame: 12 weeks
rate of chemotherapeutic complication
Time frame: 12 weeks
3-year overall survival
the cumulative overall survival rate of the patients(events defined as all caused death)
Time frame: 3 year after recruiting
disease free survival
the cumulative disease free survival rate of the patients(events defined as tumor recurrence at any sites)
Time frame: 3 year after recruiting
cumulative distant recurrence rate
cumulative recurrence rate of Rectal cancer after the radical surgery outside the pelvic cavity
Time frame: 3 year after recruiting
cumulative local recurrence rate
cumulative recurrence rate of Rectal cancer after the radical surgery within the pelvic cavity or in the wounds
Time frame: 3 year after recruiting
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