A Phase 2/3 interventional study of Oxaliplatin and Capecitabine in Rectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-14.
Sponsored by Fudan University · Phase 2/3, Interventional, and Treatment
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 240 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(RT 55Gy + CapOx) + a cycle of Xelox + Surgery
Drug: Oxaliplatin · Drug: Capecitabine · Radiation: Radiotherapy · Procedure: Surgery
(RT 50Gy + CapOx) + Surgery
Drug: Oxaliplatin · Drug: Capecitabine · Radiation: Radiotherapy · Procedure: Surgery
CRT:50mg/m2,IV,weekly\*5 cycle CT: 130mg/m2,IV,d1,q 21 day
CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
High intensity group:55Gy Low intensity group:50Gy
Lower anterior resection or abdominoperineal resection
the rate of pathological complete response (pCR)
Time frame: within 14days after surgery
toxicity
Time frame: every week during radiotherapy
local recurrence
Time frame: every half year after surgery
disease-free survival
Time frame: every half year after surgery
overall survival
Time frame: every half year after surgery
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Fudan University