Response prediction of third-line cetuximab-based therapy for patients with metastatic colorectal cancer using Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT)

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?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612000052831

Enrollment

Registered

2012-01-11

Start date

2011-07-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

1. History of another primary malignancy less than 3 years 2. Prior treatment with cetuximab or panitumumab

Outcome results