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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.

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: fludeoxyglucose F 18
Procedure: chemotherapy
Procedure: computed tomography
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: positron emission tomography
Procedure: radiation therapy
Procedure: radionuclide imaging

MedlinePlus related topics:   CT Scans    Cancer    Colorectal Cancer    Nuclear Scans   

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Jose G. Guillem, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067567, MSKCC-99048, NCI-G00-1695
First Received:   March 7, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004891
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:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




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