Trial Information

Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer

OBJECTIVES:

- Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to
CT scan at monitoring rectal cancer response to radiation and chemotherapy by
identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to
optimize selection of patients suitable for a sphincter preserving rectal cancer
resection or a local excision.

- Determine the accuracy of FDG-PET in detecting extrapelvic metastatic disease in
primary rectal cancer patients considered operable on the basis of currently accepted
diagnostic work-up, including abdominal CT scan and chest x-ray.

OUTLINE: This is a diagnostic study conducted concurrently with multimodality management.

Within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo
baseline positron emission tomography (PET) imaging of the thorax, abdomen, and pelvis.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 45 minutes later by PET imaging.
Patients also undergo baseline CT imaging of the abdomen and pelvis. A CT scan of the chest
is obtained if the prestudy chest x-ray is abnormal.

Patients receive preoperative radiotherapy/chemotherapy. Within 4-6 weeks of completion of
radiotherapy/chemotherapy, patients undergo repeat FDG-PET imaging and CT scan. Patients
undergo surgical resection 1-2 weeks later.

PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 3 years.