NCT01457599

Brief Summary

The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

5.1 years

First QC Date

October 18, 2011

Last Update Submit

August 15, 2016

Conditions

Secondary Malignant Neoplasm of Liver

Keywords

liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete responseFeasibility, safety

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Sensitivity of wire marking to find liver metastases with complete response to neoadjuvant chemotherapy

    One Year

Study Arms (1)

Marking Liver

Procedure: Computertomography-guided marking of colorectal liver metastases

Interventions

Computertomography-guided marking of colorectal liver metastasesPROCEDURE

Computertomography-guided marking of colorectal liver metastases

Marking Liver

Eligibility Criteria

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

Tertiary care clinic

You may qualify if:

  • Histologic verified cancer of the colon and rectum with metastases into the liver
  • Neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm.
  • Technically Resectability
  • Age ≥ 18 Years
  • Written informed consent

You may not qualify if:

  • Age \< 18 Years
  • Technically Irresectability
  • Neoadjuvant chemotherapy and response of metastases, however with a diameter \> 1 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Graz, Styria, 8036, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 24, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

AU(1)