Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000052831
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
11/01/2012
Date last updated
11/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Response prediction of third-line cetuximab-based therapy for patients with metastatic colorectal cancer using Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT)
Scientific title
Can early response measurement by FDG PET/CT in patients with metastatic colorectal cancer receiving third-line therapy with cetuximab predict the progression-free survival and overall survival?
Secondary ID [1] 279692 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer receiving third-line therapy with cetuximab 256415 0
Condition category
Condition code
Cancer 256588 256588 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
FDG PET/CT imaging on a dedicated PET/CT system (Siemens Biograph) is to be performed at baseline, and after one cycle and four cycles of Cetuximab therapy. CT is to be performed every 3 months to determine the progression-free survival. Patients will be followed up for at least one year. The FDG PET/CT imaging is non-invasive but requires the patients to fast for 6 hours before the examination and takes up to 3-hour stay.
Intervention code [1] 255708 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257476 0
Predictive value of response evaluation (including changes of SUV and MTV values) by FDG PET/CT for progression-free survival (assessed by RECIST criteria 1.1)
Timepoint [1] 257476 0
All participants be assessed for progression-free survival every 3 months by CT scans (RECIST criteria 1.1) up to one year after enrollment
Secondary outcome [1] 262658 0
Predictive value of response evaluation (including changes of SUV and MTV values) by FDG PET/CT for overall survival
Timepoint [1] 262658 0
All participants be assessed for overall survival up to two years after enrolment

Eligibility
Key inclusion criteria
1. at least one measurable lesion as defined by RECIST criteria.
2. received both the irinotecan-based and oxaliplatin-based regimens.
3. must have tumor specimen determined to have wild-type K-ras.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of another primary malignancy less than 3 years
2. Prior treatment with cetuximab or panitumumab

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2370 0
Taiwan, Province Of China
State/province [1] 2370 0

Funding & Sponsors
Funding source category [1] 256185 0
Hospital
Name [1] 256185 0
Chang Gung Memorial Hospital
Country [1] 256185 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital
Address
No. 5, Fusing St., Gueishan Township, Taoyuan County 33305
Country
Taiwan, Province Of China
Secondary sponsor category [1] 251528 0
University
Name [1] 251528 0
Chang Gung University College of Medicine
Address [1] 251528 0
No.259, Wenhua 1st Rd., Guishan Township, Taoyuan County 333, Taiwan
Country [1] 251528 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286455 0
Institutional Review Board of Chang Gung Memorial Hospital
Ethics committee address [1] 286455 0
5 Fu-Shin Street, Gueishan Township, Taoyuan County
Ethics committee country [1] 286455 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 286455 0
Approval date [1] 286455 0
05/07/2011
Ethics approval number [1] 286455 0
100-1877C

Summary
Brief summary
The primary objective of the current study is to determine if the change in parameters acquired by FDG-PET/CT before and 4 weeks after the initiation of cetuximab therapy is predictive of the progression-free survival (PFS) in the third-line treatment of patients with metastatic colorectal cancer
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30625 0
Address 30625 0
Country 30625 0
Phone 30625 0
Fax 30625 0
Email 30625 0
Contact person for public queries
Name 13872 0
Feng-Yuan Liu
Address 13872 0
Department of Nuclear Medicine
Chang Gung Memorial Hospital
5 Fu-Shin Street, Gueishan Township
Taoyuan County 33305
Country 13872 0
Taiwan, Province Of China
Phone 13872 0
+886, 3, 3281200
Fax 13872 0
Email 13872 0
[email protected]
Contact person for scientific queries
Name 4800 0
Feng-Yuan Liu
Address 4800 0
Department of Nuclear Medicine
Chang Gung Memorial Hospital
5 Fu-Shin Street, Gueishan Township
Taoyuan County 33305
Country 4800 0
Taiwan, Province Of China
Phone 4800 0
+886, 3, 3281200
Fax 4800 0
Email 4800 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly prediction by 18F-FDG PET/CT for progression-free survival and overall survival in patients with metastatic colorectal cancer receiving third-line cetuximab-based therapy.2015https://dx.doi.org/10.1097/RLU.0000000000000693
N.B. These documents automatically identified may not have been verified by the study sponsor.