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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NATACE-RT | Experimental | 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) |
|
| NACT-RT | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraarterial chemoembolization | Device |
| ||
| intravenous chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy |
| Measure | Description | Time Frame |
|---|---|---|
| the Sphincter Preservation Rate | 3 month | |
| Disease-free survival | Following surgery, 5 years | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wang, PH.D. | Contact | 86-23-68757151 | dongwang64@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38460248 | Derived | Qian C, Yang W, Li M, Feng Y, Dai N, Luo H, Jian D, Li X, Yang Y, He Y, Wang D, Li C, Xiao H. Negative prognostic impact of Co-mutations in TGFbeta and TP53 pathways in surgically resected rectal tumors following neoadjuvant chemoradiotherapy. Eur J Surg Oncol. 2024 Apr;50(4):108242. doi: 10.1016/j.ejso.2024.108242. Epub 2024 Mar 6. | |
| 32375814 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Device |
|
| the first day of treatment to death or last survival confirm date; assesed up to 5 years |
| Down Staging Rate | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
| Number of Participants with Adverse Events | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
| Number of Postoperative Complication | Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks) |
| Chongqing Zhongshan Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
|
| Jiangjin Central Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
|
| Yang B, Shan J, Feng Y, Dai N, Li M, Chen C, He S, Wang G, Xiao H, Li C, Wang D. Transcatheter rectal arterial chemoembolization with oxaliplatin plus S-1 concurrent chemoradiotherapy can improve the pathological remission rate in locally advanced rectal cancer: a comparative study. Radiat Oncol. 2020 May 6;15(1):94. doi: 10.1186/s13014-020-01540-4. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |