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Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer: A Feasibility Study


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer: A Feasibility Study


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.

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.

Inclusion 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

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

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior colonic, aortic, or
retroperitoneal surgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Procedures Resulting in Improved Detection

Outcome Description:

Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Timothy J. Yeatman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-11785

NCT ID:

NCT00005640

Start Date:

June 1999

Completion Date:

February 2002

Related Keywords:

  • Colorectal Cancer
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • Colorectal Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612