Studying Lymph Nodes in Patients With Stage II Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

Ultrastaging of Early Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00949312
• Other study ID #: CDR0000649763
• Secondary ID: UCLA-0809064BILA
• Status: Active, not recruiting
• Start date: May 2009
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

Genetic:
• RNA marker analysis of lymph node and primary tumors

• microarray profiling of primary tumors

• reverse transcriptase-polymerase chain reaction of lymph node specimens

Other:
• diagnostic laboratory RNA and DNA biomarker analysis of primary tumors

Procedure:
• regional lymph node dissection

Other:
• lymph node staining for H&E and pancytokeratin IHC

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
John Wayne Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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