NCT00643877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 24, 2008

Last Update Submit

March 24, 2009

Conditions

Colorectal Neoplasms

Keywords

Colorectal NeoplasmsRegionalLiverNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • 5 years disease-free survival

    5 years after operation

Secondary Outcomes (1)

  • 5 years overall survival and liver metastasis-free survival

    5 years after operation

Study Arms (2)

B

EXPERIMENTAL

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

A

NO INTERVENTION

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

Procedure: surgery

Interventions

Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDRPROCEDURE

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

B
surgeryPROCEDURE

radical surgery only

A

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33214446DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

FloxuridineSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • jianmin xu, MD

    department of general surgery, zhongshan hospital, fudan university

    STUDY CHAIR

Central Study Contacts

jianmin xu, MD

CONTACT

008613501984869xujmin@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 26, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2014

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

CN(1)