Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
* radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. * capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), * bevacizumab: at dose 5 mg/kg on days -1, 15, 31. * Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.
Cancer Hospital, CAMS
Beijing, China
RECRUITINGPathological complete remission rate (pCR)
A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR)
Time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Acute and late toxicity
Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years. late toxicites will be assessed every 6 months from the third year after surgery.
Time frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up
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