NCT00005640

Brief Summary

RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the ability to detect the extent of colorectal cancer. PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 1999

Typical duration for not_applicable colorectal-cancer

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

June 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

May 2, 2000

Last Update Submit

September 24, 2012

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 (1)

  • Number of Procedures Resulting in Improved Detection

    Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

    18 months

Study Arms (1)

Mapping and Biopsy

EXPERIMENTAL

Lymph node mapping and sentinel lymph node biopsy. Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor.

Procedure: Preoperative EndoscopyRadiation: Technetium Tc 99m Sulfur ColloidProcedure: Gamma ProbeProcedure: Biopsy of Sentinel Lymph Nodes

Interventions

Preoperative EndoscopyPROCEDURE
Mapping and Biopsy
Technetium Tc 99m Sulfur ColloidRADIATION
Mapping and Biopsy
Gamma ProbePROCEDURE
Mapping and Biopsy
Biopsy of Sentinel Lymph NodesPROCEDURE
Mapping and Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Preoperative diagnosis of stage I, II, or III colorectal cancer No more than 90 days since diagnosis No tumor involving adjacent structures (T4 lesion) No clinical or radiological evidence of stage IV disease No total excision of primary tumor at diagnosis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No severe decompensated liver disease, including cirrhosis Renal: Not specified Other: No known primary or secondary immunodeficiencies No other medical conditions or evidence of infection that would preclude study Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior colonic, aortic, or retroperitoneal surgery

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

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfur CompoundsInorganic ChemicalsTechnetium Compounds

Study Officials

  • Timothy J. Yeatman, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2000

First Posted

May 26, 2004

Study Start

June 1, 1999

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

US(1)