NCT00949312

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

14.6 years

First QC Date

July 29, 2009

Last Update Submit

March 7, 2022

Conditions

Colorectal Cancer

Keywords

stage II colon cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall survival (time to death from colorectal cancer)

    48 months

Study Arms (1)

Stage II unresected Colon Cancer

Genetic: RNA marker analysis of lymph node and primary tumorsGenetic: microarray profiling of primary tumorsGenetic: reverse transcriptase-polymerase chain reaction of lymph node specimensOther: diagnostic laboratory RNA and DNA biomarker analysis of primary tumorsProcedure: regional lymph node dissectionOther: lymph node staining for H&E and pancytokeratin IHC

Interventions

RNA marker analysis of lymph node and primary tumorsGENETIC
Stage II unresected Colon Cancer
microarray profiling of primary tumorsGENETIC
Stage II unresected Colon Cancer
reverse transcriptase-polymerase chain reaction of lymph node specimensGENETIC
Stage II unresected Colon Cancer
diagnostic laboratory RNA and DNA biomarker analysis of primary tumorsOTHER
Stage II unresected Colon Cancer
regional lymph node dissectionPROCEDURE
Stage II unresected Colon Cancer
lymph node staining for H&E and pancytokeratin IHCOTHER
Stage II unresected Colon Cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects must have CC detected by proctosigmoidoscopy, flexible endoscopy, or gastrograffin/barium enema, with no evidence of distant metastases within 8 weeks of enrollment.
  • 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.
  • Greater than 18 years of age
  • Subjects must have a performance status ≤ 2 on the ECOG/Zubrod scale.
  • Subject is able to give informed consent, and must be willing to be followed clinically or by phone/email/mail correspondence
  • Subject must have a life expectancy of greater than 5 years not including the disease/diagnosis of CC.
  • Subject must have clinical assessment conducted by phone unless patients follow up are part of the regular clinical visits.

You may not qualify if:

  • 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.
  • Subjects with any history of Crohn's disease, chronic ulcerative colitis, or familial polyposis.
  • Discovery of distant metastases intra-operatively.
  • 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).
  • 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.
  • Subjects should not be participating in another research protocol at the time of enrollment. Participation during follow-up is acceptable.
  • Systemic chemotherapy for node negative colon cancer.
  • Complete polypectomy by endoscopy
  • Less than 12 lymph nodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Related Publications (1)

  • 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.

    PMID: 26213360DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin-embedded primary tumor and lymph node sections

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Anton J. Bilchik, MD, PhD, FACS

    Saint John's Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

US(2)