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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00595725
First received: January 7, 2008
Last updated: September 7, 2011
Last verified: September 2011
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 151
Study Start Date: February 2003
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
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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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00595725     History of Changes
Other Study ID Numbers: 02-127
Study First Received: January 7, 2008
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Cervix
Endometrium
Cervical Carcinoma
Lymphatic Mapping

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases

ClinicalTrials.gov processed this record on July 29, 2014