NCT00741481

Brief Summary

Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy. FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer. SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

4.1 years

First QC Date

August 25, 2008

Last Update Submit

February 23, 2011

Conditions

Colorectal Cancer MetastaticEarly Response EvaluationFdg-PET

Keywords

metastatic colorectal cancerfdg petresponse evaluation

Outcome Measures

Primary Outcomes (1)

  • compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by time to disease progression

    Time to Disease progression

Secondary Outcomes (1)

  • compare fdg-pet variations after 1 course of chemotherapy to chemotherapy outcome measured by tumour response rate following RECIST criteria.

    response rate

Study Arms (1)

1

all study population

Procedure: FDG-PET imaging

Interventions

FDG-PET imagingPROCEDURE

FDG-PET imaging at D0 and D14 of first course of a new chemotherapy for advanced colorectal cancer

Also known as: PET-CT SCan
1

Eligibility Criteria

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

Patients \>18 yrs old advanced evaluable colorectal cancer beginning a new line of chemotherapy

You may qualify if:

  • advanced colorectal cancer
  • evaluable disease
  • signed informed consent

You may not qualify if:

  • no other cancer
  • no other life-threatening condition
  • unwillingness or inability to sign informed consent
  • active cerebral metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet, Université Libre de Bruxelles

Brussels, 1190, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Alain - Hendlisz, MD

    Institut Jules Bordet, Université Libre de Bruxelles, Brussels

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

June 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

BE(1)