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Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing

Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing


- To determine the accuracy and sensitivity of intraoperative lymph node mapping with
isosulfan blue and sentinal node biopsy (SLN) in patients with colorectal cancer (CRC).

- To compare molecular and immunohistochemical methods for detection of micrometastases
in the SLN and primary tumor and evaluate the clinical outcome.

- To evaluate the clinicopathological utility of hematogenous micrometastases in
predicting disease recurrence in CRC.

OUTLINE: Patients receive isosulfan blue subserosally around the primary tumor for sentinel
lymph node (SLN) identification and SLN(s) are marked. Patients undergo a standard colon
resection as planned to include the SLN(s) and regional lymph nodes.

Lymph nodes removed during surgery are analyzed within 30 days after surgery. Routine
pathologic analysis (H&E) are performed on all lymph nodes (SLN and non-SLN) removed.
Immunohistochemical (IHC) staining for cytokeratin antibodies AE-1/AE-3 or MAK-6 are
performed on all lymph nodes negative by H&E. Multimarker PCR (MM PCR) are performed on all
SLNs. Blood samples are collected at baseline and then periodically for 4 years for MM PCR
to detect circulating tumor cells and standard tumor markers (e.g., CEA).

After surgery, patients are followed every 6 months for 4 years.

Inclusion Criteria


- Diagnosis of colorectal cancer as detected by proctosigmoidoscopy, flexible
endoscopy, or gastrografin/barium enema

- No evidence of distant metastases by CT scan of the abdomen and pelvis AND chest
x-ray or CT scan of the chest performed within 6 weeks prior to enrollment

- Preoperative CT scans and testing showing non-specific or non-diagnostic
(equivocal) abnormalities may be eligible pending intraoperative exploration

- No discovery of distant metastases intra-operatively


- ECOG performance status (PS) or Zubrod PS equal to 2

- Life expectancy > 5 years not including the disease/diagnosis of colorectal cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No requirement for emergent surgery (within 2 hours of presentation) to prevent a
life-threatening situation or death including:

- Perforated colon

- Metabolically significant complete bowel obstruction

- Massive GI bleeding

- Occult bleeding or early or partial bowel obstruction not requiring emergent
surgery allowed

- No history of Crohn disease, chronic ulcerative colitis, or familial polyposis

- No other malignancy within the past 3 years except for completely resected cervical
cancer, skin cancer, or in situ cancer


- See Disease Characteristics

- See Patient Characteristics

- No concurrent participation in another research protocol

- Participation during follow up allowed

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and accuracy of lymphatic mapping in colorectal cancer

Safety Issue:


Principal Investigator

Shamim Baker

Investigator Affiliation:

John Wayne Cancer Institute at Saint John's Health Center


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

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