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Home > "L" Clinical Trials Conditions > Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer  Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
For Condition: stage 1 rectal cancer,stage 3 rectal cancer,stage 1 colon cancer,stage 3 colon cancer,stage 2 colon cancer,stage 2 rectal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy , may improve the ability to detect the extent of colorectal cancer. PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.
Details: OBJECTIVES: I. Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. II. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. III. Identify patients with histologically negative nodes but have positive nodes on further detailed examination. PROTOCOL OUTLINE: Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor. Patients are followed postoperatively, every 4-6 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Preoperative diagnosis of stage I, II, or III colorectal cancer; No more than 90 days since diagnosis - No tumor involving adjacent structures (T4 lesion) - No clinical or radiological evidence of stage IV disease - No total excision of primary tumor at diagnosis --Prior/Concurrent Therapy-- - See Disease Characteristics - No prior colonic, aortic, or retroperitoneal surgery --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: No severe decompensated liver disease, including cirrhosis - Renal: Not specified - Other: No known primary or secondary immunodeficiencies; No other medical conditions or evidence of infection that would preclude study; Not pregnant; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyYeatman, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Additional Information:
Study ID Numbers: CDR0000067803; MCC-11785,NCI-G00-1780,MCC-IRB-5033
Study Start Date: June 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005640
Other Stage 1 Rectal Cancer Studies:
1. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Genetic Study of Familial Factors in Patients With Colon Cancer
4. Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
5. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
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Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
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