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NCT Number: NCT00869271

Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer

The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

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Key information

Conditions

Unresectable Liver Metastasis of Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • with measurable unresectableliver metastasis
  • without other metastasis

Exclusion criteria

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • prior cancer therapy
  • with other metastasis

Treatment and study plan

tac + folfox4

Procedure

tac: oxaliplatin 100mg + fudr 1g + mmc 10mg

folfox4

Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.

Folfox4

Procedure

folfox4

Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle

Primary outcomes

  1. overall survival

    Time frame: 5 years after diagnosis

Secondary outcomes

  1. progression free survival

    Time frame: 5 years after diagonsis

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 25, 2009
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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