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Completed

NCT Number: NCT00004891

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Computed Tomography

Procedure

conventional surgery

Procedure

neoadjuvant therapy

Procedure

Positron Emission Tomography

Procedure

radionuclide imaging

Procedure

fludeoxyglucose F 18

Radiation

radiation therapy

Radiation

Primary outcomes

  1. Determine if fludeoxyglucose F 18 positron emission tomography (FDG-PET) is superior to CT scan

    Time frame: 2 years

    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

Secondary outcomes

  1. Determine the accuracy of FDG-PET

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
First posted
Jan 27, 2003
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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