RecruitingACTRN12612000052831

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?


Sponsor

Chang Gung Memorial Hospital

Enrollment

30 participants

Start Date

Jul 5, 2011

Study Type

Observational

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • at least one measurable lesion as defined by RECIST criteria.
  • received both the irinotecan-based and oxaliplatin-based regimens.
  • must have tumor specimen determined to have wild-type K-ras.

Exclusion Criteria2

  • History of another primary malignancy less than 3 years
  • Prior treatment with cetuximab or panitumumab

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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 det

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.


Locations(1)

Taiwan, Province Of China

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ACTRN12612000052831