Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer
By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1. Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus. 2. At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations.
Three-dimensional conformal radiotherapy as following: CTV 44Gy/22 times+GTV1 6Gy/3 times(2Gy/time/day,5 days a week,totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGDisease Free Survival (DFS)
the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Time frame: 3 years
Surgery related mortality and complication
Surgery related mortality and complication
Time frame: 3 years
Resection rate of R0
Resection rate of R0
Time frame: 3 years
Pathologic complete remission (pCR) rate
Pathologic complete remission (pCR) rate
Time frame: 3 years
Tolerance after neoadjuvant treatment
Tolerance after neoadjuvant treatment
Time frame: 3 years
Predictor efficacy of neoadjuvant chemotherapy for DFS
Predictor efficacy of neoadjuvant chemotherapy for DFS
Time frame: 3 years
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CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks