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Home > "D" Clinical Trials Conditions > Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer  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 1 Rectal Cancer Studies:
1. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
2. Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases from Colorectal Cancer
3. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
4. Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
5. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Related Studies:
Other stage 1 rectal cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
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