Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Device: intravenous chemotherapy; Device: intraarterial chemoembolization

• Registration Number: NCT03601156
• Lead Sponsor: Third Military Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-04-23
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-10
• Primary Completion: 2018-12
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NACT-RT	intravenous chemotherapy	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)
NATACE-RT	intraarterial chemoembolization	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)

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response (pCR)	pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy	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

Secondary Outcome Measures

Name	Time	Method
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
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)
the Sphincter Preservation Rate	3 month
Down Staging Rate	Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)

Trial Locations

Locations (3)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Chongqing Zhongshan Hospital; 🇨🇳 Chongqing, Chongqing, China

Jiangjin Central Hospital; 🇨🇳 Chongqing, Chongqing, China