An interventional study of intraarterial chemoembolization and intravenous chemotherapy in Rectal Cancer, sponsored by Third Military Medical University. Status unknown at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 204 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive Oxaliplatin 130mg/m2 intraarterial chemoembolization on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA \< 1.25 mm2 receive 80 mg/day; 1.25 mm2 \< BSA \< 1.5mm2 recive 100 mg/day, BSA\>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)
Device: intraarterial chemoembolization
Patients receive Oxaliplatin 130mg/m2 intravenous chemotherapy on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA \< 1.25 mm2 receive 80 mg/day; 1.25 mm2 \< BSA \< 1.5mm2 recive 100 mg/day, BSA\>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)
Device: intravenous chemotherapy
Pathological Complete Response (pCR)
Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes
Time frame: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
the Sphincter Preservation Rate
Time frame: 3 month
Disease-free survival
Time frame: Following surgery, 5 years
Overall Survival
Time frame: the first day of treatment to death or last survival confirm date; assesed up to 5 years
Down Staging Rate
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Participants with Adverse Events
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Number of Postoperative Complication
Time frame: Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Third Military Medical University