NCT00595725

Brief Summary

The purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes. Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries. The treatment also includes removing lymph nodes from the pelvis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

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

February 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 8, 2011

Status Verified

September 1, 2011

Enrollment Period

8.6 years

First QC Date

January 7, 2008

Last Update Submit

September 7, 2011

Conditions

Cervical CancerEndometrial CancerCervical Carcinoma

Keywords

CervixEndometriumCervical CarcinomaLymphatic Mapping

Outcome Measures

Primary Outcomes (1)

  • To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.

    7 years

Secondary Outcomes (2)

  • To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.

    7 years

  • To document the location of the sentinel nodes in patients with invasive cervical cancer.

    7 years

Study Arms (1)

1

EXPERIMENTAL
Other: Lymphatic Mapping

Interventions

Lymphatic MappingOTHER

Intra-Operative Lymphatic Mapping

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage.
  • Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy.
  • Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix).
  • Patients with stage I to \~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix).
  • Patients with clinical stage I endometrial cancer
  • Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy
  • Patients who have signed an approved informed consent.

You may not qualify if:

  • Patients with history of prior pelvic or para-aortic lymphadenectomy.
  • Patients with stage IIB-IV invasive cervical cancer by FIGO criteria.
  • Patients with recurrent endometrial or cervical cancer.
  • Patients with prior pelvic radiation.
  • Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy.
  • Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix).
  • Patients with grossly infected primary tumors.
  • Patients with known allergy to triphenyl-ethane compounds.
  • Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase.
  • Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies.
  • Severe Renal Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Mary Gemignani, MD

    Memorial Sloan Kettering Cancer Center

    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

January 7, 2008

First Posted

January 16, 2008

Study Start

February 1, 2003

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 8, 2011

Record last verified: 2011-09

Locations

US(1)