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

Completed · Not applicable

Conditions studied: Cervical Cancer, Endometrial Cancer, Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT00595725

Run by

Memorial Sloan Kettering Cancer Center

People needed

151

Starts

2003-02-01

Expected to finish

2011-09-01

Last updated by the study team

2011-09-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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