NCT01677728

Brief Summary

The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2007

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

6.9 years

First QC Date

August 30, 2012

Last Update Submit

August 30, 2012

Conditions

Colorectal CancerLiver Tumor

Keywords

colorectal liver metastaseschemotherapycetuximabbevacizumab

Study Arms (2)

arm A

patients received chemotherapy alone

arm B

patients received target therapy combined with chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From Zhongshan hospital

You may qualify if:

  • age between 18 - 75 years old
  • Performance status (ECOG) 0\~1
  • colorectal adenocarcinoma pathologically
  • without any chemotherapy or radiotherapy
  • liver metastases undergoing radical resection
  • colorectal cancer undergoing radical resection
  • no other metastases
  • suitable for chemotherapy
  • agreed by patients

You may not qualify if:

  • age below 18 years old or greater than 75 years old
  • haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase
  • with any chemotherapy or radiotherapy
  • with other metastasis
  • unresectable colorectal cancer or liver metastases
  • unsuitable for chemotherapy or target therapy
  • not agreed by patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver Diseases

Study Officials

  • Xu Jianmin, MD

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Central Study Contacts

Xu Jianmin, MD

CONTACT

+86-13501984869xujmin@yahoo.com.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Zhongshan hospital

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

CN(1)