Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer (PCAR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: intraarterial chemoembolization; Device: intravenous chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Daping Hospital, Third Military Medical University
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing Zhongshan Hospital
      • Contact: Zhixiang Yang, M.D.; Phone Number: 86-13032372491
      • Principal Investigator: Zhixiang Yang, M.D.
    • Chongqing, Chongqing, China
      • Recruiting
      • Jiangjin Central Hospital
      • Contact: Debing Xiang, M.D.; Phone Number: 86-13320336639
      • Principal Investigator: Debing Xiang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NATACE-RT; 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
Active Comparator: NACT-RT; 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

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Third Military Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: rectal cancer; Oxaliplatin; radiotherpy; intraarterial chemoembolization; Tegafur Gimeracil and Oteracil Porassium Capsule
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PCAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No