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Status unknownNCT00874406Updated Apr 2, 2009

Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

A Phase 4 interventional study of tac + folfox4 and folfox4 in Colorectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-04-02.

Sponsored by Fudan University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Read the detailed description

We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • liver metastasis
  • neoadjuvant chemotherapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age \<= 75 years
  • resectable liver metastasis
  • remnant liver volume >= 70%
  • without other organ metastasis or peritoneum metastasis
  • without contradiction of cardiac and pulmonary diseases

Exclusion criteria

Exclusion Criteria:

  • age > 75 years
  • unresectable liver metastasis
  • remnant liver volume \< 50%
  • with other organ metastasis or peritoneum metastasis
  • with contradiction of cardiac and pulmonary diseases
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    1

    transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

    Drug: tac + folfox4

  • Active comparator
    2

    Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.

    Drug: folfox4

Interventions

  • Drugtac + folfox4

    tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4

  • Drugfolfox4

    folfox4 will be done within 28 days after liver resection

06

What researchers measure

Primary outcomes

  1. progression free survival

    Time frame: 5 years after operation

Secondary outcomes

  1. overall survival

    Time frame: 5 years after operation

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai 200032, China
    • jianmin xu, MD, PHD · Contact · xujmin@yahoo.com.cn · 008613501984869
    • jianmin xu, MD, PHD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00874406
Lead sponsor
Fudan University
First posted
Apr 2, 2009
Start date
Jan 2008
Primary completion
Dec 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Apr 2, 2009

Study contacts

jianmin xu, MD, PHD
Contact
xujmin@yahoo.com.cn
008613501984869
jianmin xu, MD, PHD
principal investigator · 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 Apr 2009. You cannot join it, but the record below documents what was studied.

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