Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer

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

RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.

PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients with colorectal cancer.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Other: diagnostic laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: polymerase chain reaction; Drug: isosulfan blue; Procedure: diagnostic lymphadenectomy; Procedure: therapeutic lymphadenectomy

Detailed Description

OBJECTIVES:

• 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.

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• See Patient Characteristics

• No concurrent participation in another research protocol

  • Participation during follow up allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Disease-free survival
Sensitivity and accuracy of lymphatic mapping in colorectal cancer

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Shamim Baker, Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Anticipated): November 1, 2007

Study Registration Dates

• First Submitted: February 27, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): February 28, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; stage I rectal cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000586464; JWCI-GULS-CRCSLN-0104