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



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

For Condition: Stage 4 rectal cancer,stage 3 rectal cancer,stage 2 rectal cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advancedprimary rectal cancer and may also help to measure a patient's response to treatment. PURPOSE: Diagnostic trial to study the effectiveness of PET and CT scans to detect residual or metastatic disease in patients who have locally advanced primary rectal cancer that can be removed during surgery.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JoseGuillem,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Jose  Guillem 212-639-8278


Additional Information:
Study ID Numbers:
  CDR0000067567;  MSKCC-99048,NCI-G00-1695
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004891

Other Stage 2 Rectal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

2. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen

3. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer

4. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer

5. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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

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