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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intraarterial chemoembolization
intravenous chemotherapy
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Daping Hospital, Third Military Medical UniversityRecruiting
  • Chongqing Zhongshan HospitalRecruiting
  • Jiangjin Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NATACE-RT

NACT-RT

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the Sphincter Preservation Rate
Disease-free survival
Overall Survival
Down Staging Rate
Number of Participants with Adverse Events
Number of Postoperative Complication

Full Information

First Posted
April 23, 2015
Last Updated
August 8, 2018
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03601156
Brief Title
Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer
Acronym
PCAR
Official Title
Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, intraarterial chemoembolization, radiotherpy, Oxaliplatin, Tegafur Gimeracil and Oteracil Porassium Capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NATACE-RT
Arm Type
Experimental
Arm Description
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)
Arm Title
NACT-RT
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
intraarterial chemoembolization
Intervention Type
Device
Intervention Name(s)
intravenous chemotherapy
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR)
Description
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
Secondary Outcome Measure Information:
Title
the Sphincter Preservation Rate
Time Frame
3 month
Title
Disease-free survival
Time Frame
Following surgery, 5 years
Title
Overall Survival
Time Frame
the first day of treatment to death or last survival confirm date; assesed up to 5 years
Title
Down Staging Rate
Time Frame
Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Title
Number of Participants with Adverse Events
Time Frame
Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)
Title
Number of Postoperative Complication
Time Frame
Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Wang, PH.D.
Phone
86-23-68757151
Email
dongwang64@hotmail.com
Facility Information:
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.
Phone
86-23-68757151
Email
dongwang64@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dong Wang, PH.D.
Facility Name
Chongqing Zhongshan Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiang Yang, M.D.
Phone
86-13032372491
First Name & Middle Initial & Last Name & Degree
Zhixiang Yang, M.D.
Facility Name
Jiangjin Central Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debing Xiang, M.D.
Phone
86-13320336639
First Name & Middle Initial & Last Name & Degree
Debing Xiang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
32375814
Citation
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.
Results Reference
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Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

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