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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00595725

Collaborator

(none)

151

Enrollment

Location

Arm

103

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Endometrial Cancer Cervical Carcinoma	Other: Lymphatic Mapping	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

151 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Other: Lymphatic Mapping Intra-Operative Lymphatic Mapping

Arm

Intervention/Treatment

Experimental: 1

Other: Lymphatic Mapping

Intra-Operative Lymphatic Mapping

Outcome Measures

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. [7 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.