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Status unknownNCT00643877PHRACUpdated Mar 25, 2009

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

A Phase 3 interventional study of Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR and surgery in Colorectal Neoplasms, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2009-03-25.

Sponsored by Fudan University · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Neoplasms

Keywords

  • Colorectal Neoplasms
  • Regional
  • Liver
  • Neoplasm Metastasis
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 600 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    B

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

    Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR

  • No intervention
    A

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

    Procedure: surgery

Interventions

  • ProcedurePreoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR

    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

  • Proceduresurgery

    radical surgery only

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What researchers measure

Primary outcomes

  1. 5 years disease-free survival

    Time frame: 5 years after operation

Secondary outcomes

  1. 5 years overall survival and liver metastasis-free survival

    Time frame: 5 years after operation

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Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, 200032, China
    • jianmin xu, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33214446 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00643877
Lead 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 Cancer Hospital & Institute
First posted
Mar 26, 2008
Start date
Dec 2008
Primary completion
Dec 2009 (estimated)
Completion
Dec 2014 (estimated)
Last update
Mar 25, 2009

Study contacts

jianmin xu, MD
Contact
xujmin@yahoo.com.cn
008613501984869
jianmin xu, MD
study chair · department of general surgery, zhongshan hospital, fudan university

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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