NCT00003186

Brief Summary

RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

7.9 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal canceradenocarcinoma of the colonliver metastases

Interventions

isosulfan blueDRUG
lymphangiographyPROCEDURE
sentinel lymph node biopsyPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Patients must be undergoing surgical resection of a colorectal primary adenocarcinoma Metastatic colorectal cancer to liver (hepatic metastases) allowed PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known or suspected allergy to isosulfan blue Not pregnant PRIOR CONCURRENT THERAPY: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

  • Kane JM 3rd, Kahlenberg MS, Rodriguez-Bigas MA, Gibbs JF, Petrelli NJ. Intraoperative hepatic lymphatic mapping in patients with liver metastases from colorectal carcinoma. Am Surg. 2002 Sep;68(9):745-50.

    PMID: 12356141RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

iso-sulfan blueSentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Miguel A. Rodriguez-Bigas, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 19, 2004

Study Start

April 1, 1997

Primary Completion

March 1, 2005

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)