NCT00625625

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

September 17, 2013

Status Verified

February 1, 2008

Enrollment Period

3.7 years

First QC Date

February 27, 2008

Last Update Submit

September 16, 2013

Conditions

Colorectal Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancer

Outcome Measures

Primary Outcomes (3)

  • Sensitivity and accuracy of lymphatic mapping in colorectal cancer

  • Overall survival

  • Disease-free survival

Interventions

isosulfan blueDRUG
polymerase chain reactionGENETIC
diagnostic laboratory biomarker analysisOTHER
immunohistochemistry staining methodOTHER
diagnostic lymphadenectomyPROCEDURE
therapeutic conventional surgeryPROCEDURE
therapeutic lymphadenectomyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

iso-sulfan bluePolymerase Chain ReactionImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Shamim Baker

    Saint John's Cancer Institute

Study Design

Study Type
interventional
Phase
phase 2
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

February 28, 2008

Study Start

March 1, 2004

Primary Completion

November 1, 2007

Last Updated

September 17, 2013

Record last verified: 2008-02