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Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer (PHRAC)

Primary Purpose

Colorectal Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
surgery
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, Regional, Liver, Neoplasm Metastasis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age < 75 years with histologically proven adenocarcinoma of the colon or rectum
  • no severe major organ dysfunction
  • WHO performance status of 0 or 1
  • no prior cancer therapy
  • Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan

Exclusion Criteria:

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • prior cancer therapy
  • Stage I or Stage IV

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

B

A

Arm Description

PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.

Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.

Outcomes

Primary Outcome Measures

5 years disease-free survival

Secondary Outcome Measures

5 years overall survival and liver metastasis-free survival

Full Information

First Posted
March 24, 2008
Last Updated
March 24, 2009
Sponsor
Fudan University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Jiangyin People's Hospital, Liaoning Tumor Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00643877
Brief Title
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
Acronym
PHRAC
Official Title
A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University, Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, First Affiliated Hospital of Zhejiang University, Jiangyin People's Hospital, Liaoning Tumor Hospital & Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection.
Detailed Description
We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Neoplasms, Regional, Liver, Neoplasm Metastasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
Arm Title
A
Arm Type
No Intervention
Arm Description
Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
Intervention Type
Procedure
Intervention Name(s)
Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
Intervention Description
PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
radical surgery only
Primary Outcome Measure Information:
Title
5 years disease-free survival
Time Frame
5 years after operation
Secondary Outcome Measure Information:
Title
5 years overall survival and liver metastasis-free survival
Time Frame
5 years after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age < 75 years with histologically proven adenocarcinoma of the colon or rectum no severe major organ dysfunction WHO performance status of 0 or 1 no prior cancer therapy Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan Exclusion Criteria: age >= 75 severe major organ dysfunction WHO performance status of >1 prior cancer therapy Stage I or Stage IV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin xu, MD
Phone
008613501984869
Email
xujmin@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD
Organizational Affiliation
department of general surgery, zhongshan hospital, fudan university
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33214446
Citation
Zhu D, Xia J, Gu Y, Lin J, Ding K, Zhou B, Liang F, Liu T, Qin C, Wei Y, Ren L, Zhong Y, Wang J, Yan Z, Cheng J, Chen J, Chang W, Zhan S, Ding Y, Huo H, Liu F, Sun J, Qin X, Xu J. Preoperative Hepatic and Regional Arterial Chemotherapy in Patients Who Underwent Curative Colorectal Cancer Resection: A Prospective, Multi-center, Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1066-1075. doi: 10.1097/SLA.0000000000004558.
Results Reference
derived

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Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer

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