A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal
cancer. Pathological complete response (pCR) is an important prognostic factor for local
control and survival. A high intensity CRT increases not only the pCR rate, but also
toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified
radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high
dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose
intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose
induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT
includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine
weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a
cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8
weeks after CRT.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Fudan University
Collaborators:
First Affiliated Hospital of Zhejiang University First People Hospital of Zhejiang RenJi Hospital Zhejiang Cancer Hospital