Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: intraarterial chemoembolization
* Device: intravenous chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of rectal cancer, Stage IV. Males or females between 18 Years to 75 Years. No prior cisplatin-based chemotherapy or radiotherapy. Performance status of 0～2 on the ECOG criteria. Adequate hematologic (Leukocyte count >= 4,000/uL, neutrophil count >= 1,500/uL, hemoglobin >= 10 g/dL, platelets >= 100,000/uL), hepatic (AST & ALT =< upper normal limit(UNL)x1.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function. Patient can take oral medicine Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative. Exclusion Criteria: Patient with allergic to S-1 or ingredient of Oxaliplatin Patient with Peripheral neuropathy Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days. Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes. Enrollment in other study. Pregnant or breast-feeding. Seriously psyche or intelligence problem. Inability to comply with protocol or study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NATACE-RT<br>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<br> <br> |
| Active Comparator: NACT-RT<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Sphincter Preservation Rate |  | 3 month | 
| Disease-free survival |  | Following surgery, 5 years | 
| Overall Survival |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule