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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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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.

Inclusion 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

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)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jose G. Guillem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067567

NCT ID:

NCT00004891

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021