Studying Lymph Nodes in Patients With Stage II Colon Cancer

Ultrastaging of Early Colon Cancer

RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.

PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: regional lymph node dissection; Genetic: RNA marker analysis of lymph node and primary tumors; Genetic: microarray profiling of primary tumors; Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens; Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors; Other: lymph node staining for H&E and pancytokeratin IHC

Detailed Description

OBJECTIVES:

• Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
• Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.

OUTLINE: This is a multicenter study.

Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.

Patients are followed up periodically for 4 years after surgery.

• Study Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From the ambulatory cancer clinic, we will identify 300 stage II colon cancer patients eligible for the study.

Description

Inclusion Criteria: All of the following inclusion criteria must be met in order for the subject to be eligible.

1. Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
2. Subjects with CC must have a computerized tomography (CT; at a minimum - spiral (helical) CT with 5-mm contiguous reconstruction algorithms and adequate volume (based on site-specific protocols) of oral and intravenous contrast agents) of the abdomen and pelvis and a chest x-ray or CT of the chest per standard of care, within 8 weeks prior to enrollment to rule out distant metastases. Subjects with preoperative CT scans and testing showing non-specific or non-diagnostic (equivocal) abnormalities may be eligible pending intraoperative exploration.
3. Greater than 18 years of age
4. Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
5. Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
6. Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
7. Subject must have clinical assessment conducted by phone unless patients follow up are part of the regular clinical visits.

Exclusion Criteria: Any of the following criteria will exclude the subject from the study.

1. Subjects requiring emergent surgery (within 2 hours of presentation) to prevent a life-threatening situation or death such as those with a perforated colon, metabolically significant complete bowel obstruction or massive GI bleeding will be excluded. Subjects who do not require emergent surgery, such as those with occult bleeding or early or partial bowel obstruction will be permitted to enter.
2. Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
3. Discovery of distant metastases intra-operatively.
4. Subjects with history of another malignancy over the last three years (except for completely resected cervical, skin cancers or in-situ cancers - see Appendix B for a list of exempt cancers).
5. Pregnant and/or lactating women. Potentially childbearing subjects (pre-menopausal women) should undergo a pregnancy test within 7 days prior to surgery and after signing consent. Subjects found to be pregnant will be ineligible and withdrawn from the study.
6. Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
7. Systemic chemotherapy for node negative colon cancer.
8. Complete polypectomy by endoscopy
9. Less than 12 lymph nodes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage II unresected Colon Cancer	Procedure: regional lymph node dissection; Genetic: RNA marker analysis of lymph node and primary tumors; Genetic: microarray profiling of primary tumors; Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens; Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors; Other: lymph node staining for H&E and pancytokeratin IHC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (time to local or distant recurrence after resection)	The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (time to death from colorectal cancer)	The event to be used for DFS is time to death after resection of colon cancer	48 months

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Anton J. Bilchik, MD, PhD, FACS, Saint John's Cancer Institute

Publications and helpful links

General Publications

• Protic M, Stojadinovic A, Nissan A, Wainberg Z, Steele SR, Chen DC, Avital I, Bilchik AJ. Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial. J Am Coll Surg. 2015 Sep;221(3):643-51; quiz 783-5. doi: 10.1016/j.jamcollsurg.2015.05.007. Epub 2015 May 18.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 29, 2009
• First Posted (Estimate): July 30, 2009

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: stage II 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; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CDR0000649763; UCLA-0809064; BILA-UECC-0107; IRB# 08-09-064-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No