Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic, Treatment Closed 18 and over NCI MSKCC-99048 NCI-G00-1695, NCT00004891

Objectives

1. 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.
2. 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.

Entry Criteria

Disease Characteristics:

• Primary resectable rectal cancer as determined by currently accepted diagnostic work-up, including CT scan and endorectal ultrasound (EUS)



• Must meet criteria for preoperative radiotherapy and chemotherapy:
  • Bulky tumors and/or EUS evidence of T3-4 and/or N1 disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• No uncontrolled diabetes mellitus (i.e., greater than 175 mg/dL)
• No intolerance of being inside PET scanner for duration of study
• No vulnerable patients (e.g., mentally retarded or prisoners)

Expected Enrollment

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

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.

Nahas CS, Akhurst T, Yeung H, et al.: Positron emission tomography detection of distant metastatic or synchronous disease in patients with locally advanced rectal cancer receiving preoperative chemoradiation. Ann Surg Oncol 15 (3): 704-11, 2008.[PUBMED Abstract]

Guillem JG, Puig-La Calle J Jr, Akhurst T, et al.: Prospective assessment of primary rectal cancer response to preoperative radiation and chemotherapy using 18-fluorodeoxyglucose positron emission tomography. Dis Colon Rectum 43 (1): 18-24, 2000.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Jose Guillem, MD, Protocol chair		Ph: 212-639-8278; 800-525-2225 Email: guillemj@mskcc.org

Registry Information
Official Title		Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer
Trial Start Date		1999-09-14
Registered in ClinicalTrials.gov		NCT00004891
Date Submitted to PDQ		1999-12-14
Information Last Verified		2006-03-22
NCI Grant/Contract Number		CA08748

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