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PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004891
  Purpose

RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment.

PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.


Condition Intervention
Colorectal Cancer
Drug: chemotherapy
Procedure: computed tomography
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: positron emission tomography
Procedure: radionuclide imaging
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy

MedlinePlus related topics: CT Scans Cancer Colorectal Cancer Nuclear Scans Radiation Therapy Surgery
Drug Information available for: Fluorodeoxyglucose F18
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Prospective Evaluation of 18F-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) in the Multimodality Management of Locally Advanced Primary Rectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004891

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Jose G. Guillem, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067567, MSKCC-99048, NCI-G00-1695
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004891     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer

Study placed in the following topic categories:
Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Rectal Neoplasm
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009