The purpose of this study is to evaluate the safety and efficacy of preoperative chemoradiotherapy (IMRT) with concurrent high-dose intravenous vitamin C and mFOLFOX6 in locally advanced rectal cancer patients.
Sixty patients with locally advanced rectal cancer (cT3-4N0M0, cT1-4N1-2M0, ≤12cm from anus) will be enrolled and receive preoperative IMRT concurrent with high-dose intravenous vitamin C and 2-3 cycles of mFOLFOX6 chemotherapy, and then after 4 weeks rest, they will continue to complete 3 cycles of preoperative chemotherapy (mFOLFOX6). Radical surgery will be performed at 10-12 weeks after IMRT. In this study, we will evaluate the safety and effectiveness of the treatment method through the acute toxicity \[during CRT (concurrent chemoradiotherapy )\], PCR (pathologic complete response) rate, sphincter preserving surgery rate, 2-year survival rate and 2-year disease-free survival rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
High-dose Intravenous Vitamin C will be delivered on the day of radiotherapy, in order to reduce the acute toxicity of chemoradiotherapy.
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, China
RECRUITINGPCR rate
The PCR rate is defined as the percentage of subjects who achieved Pathological complete remission(PCR) in the total number of the subjects who underwent surgery in the ITT population.
Time frame: 2 year From the first subject underwent surgery to the last subject underwent surgery.
acute toxicity
acute toxicity including diarrhea, vomiting leukopenia, er al, during the preoperative CRT and high-dose intravenous vitamin C and 30 after the radiotherapy.
Time frame: 2 year
Resection rate of anus preserving surgery
In patients with low rectal cancer, the percentage of subjects who underwent anus preserving surgery accounted for the total TME surgery.
Time frame: 2 year From the first subject underwent surgery to the last subject underwent surgery.
2-year survival rate
2-year survival rate of ITT (Intent to treat) population.
Time frame: up to 2 years after the last subject being enrolled
2-year disease-free survival rate
2-year disease-free survival rate of ITT population.
Time frame: up to 2 years after the last subject being enrolled.
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