To hear about similar clinical trials, please enter your email below

Trial Title: Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

NCT ID: NCT00868569

Condition: Liver Metastasis
Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin

Conditions: Keywords:
liver metastasis
colorectal cancer
oxaliplatine
transartery chemotherapy
embolision
Unresectable Liver Metastasis of Colorectal Cancer

Study type: Interventional

Study phase: Phase 4

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: TACE + folfox 4
Description: tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml folfox4
Arm group label: 1

Intervention type: Procedure
Intervention name: TAC + folfox4
Description: tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4
Arm group label: 2

Summary: The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Detailed description: We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) 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.

Criteria for 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 - 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhongshan Hospital, Fudan University

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: jianmin xu, MD, PHD

Phone: 008613501984869
Email: xujmin@yahoo.com.cn

Investigator:
Last name: jianmin xu, MD, PHD
Email: Principal Investigator

Start date: January 2008

Completion date: December 2010

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00868569

Login to your account

Did you forget your password?