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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595725
• Other study ID #: 02-127
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: September 7, 2011
• Start date: February 2003
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Cervical Cancer
• Cervical Carcinoma
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• Lymphatic Mapping
Intra-Operative Lymphatic Mapping

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.		7 years	No
Secondary	To document the location of the sentinel nodes in patients with invasive cervical cancer.		7 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center