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Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer



Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

For Condition: Stage 4 rectal cancer,liver metastases,stage 4 colon cancer,stage 2 colon cancer,adenocarcinoma of the colon,stage 3 rectal cancer,stage 2 rectal cancer,stage 3 colon cancer,stage 1 colon cancer,stage 1 rectal cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
Synopsis: RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.
Details: OBJECTIVES: I. Confirm that injection of isosulfan blue into the mucosa or serosa immediately adjacent to a colorectal cancer results in the lymphatic transport of that agent initially to a specific regional lymph node that can readily be identified on visual inspection, dissected, and histologically evaluated for the presence or absence of metastatic disease. PROTOCOL OUTLINE: All patients receive an injection of isosulfan blue into peritumor serosa upon intraoperative identification of the primary tumor, prior to mesenteric mobilization. If colonoscopy is otherwise indicated, the injection may be delivered to the peritumor mucosa via colonoscopy during the case. The mesentery adjacent to the injection is inspected and the lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and photographed. The sentinel node(s) are surgically dissected and evaluated. If needed, a second injection of isosulfan blue may be given. Prior to mobilization of liver for resection of metastases, isosulfan blue is injected subcapsularly around the metastatic lesion. PROJECTED ACCRUAL: There will be 10 patients accrued into this study.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Patients must be undergoing surgical resection of a colorectal primary adenocarcinoma - Metastatic colorectal cancer to liver (hepatic metastases) allowed --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 18 to 75 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No known or suspected allergy to isosulfan blue; Not pregnant
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MiguelRodriguez-Bigas,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066015;  RPCI-DS-96-57,NCI-G98-1371
Study Start Date: April 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003186

Other Stage 4 Rectal Cancer Studies:
1. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

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

3. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma

4. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed

5. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

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