Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00595725

Purpose

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.

Condition	Intervention
Cervical Cancer Endometrial Cancer Cervical Carcinoma	Other: Lymphatic Mapping

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
To document the location of the sentinel nodes in patients with invasive cervical cancer. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2003
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: Lymphatic Mapping Intra-Operative Lymphatic Mapping

Detailed Description:

Patients with FIGO stage I endometrial cancer or patients with FIGO stage I-IIA invasive cervical cancer and who will be undergoing surgical management to include a lymphadenectomy.

↓ Injection of radioisotope and preoperative lymphoscintigraphy with Tc99m either the day before or on the day of surgery by the Nuclear Medicine Department.

↓ Intraoperative lymphatic mapping with blue dye and gamma probe.

↓ Hysterectomy, Radical hysterectomy and/or radical trachelectomy and pelvic lymphadenectomy.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595725

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Mary Gemignani, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Gemignani, Mary, MD )
Study ID Numbers:	02-127
Study First Received:	January 7, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00595725
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Cervix
Endometrium
Cervical Carcinoma
Lymphatic Mapping

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms

Urogenital Neoplasms
Endometrial cancer
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009