Clinical trial NCT00595725: Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
Official title: Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Endometrial Cancer
Cervical Carcinoma
Keywords: Cervix
Endometrium
Cervical Carcinoma
Lymphatic Mapping
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 7 years
Secondary outcomes:
measure: To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
timeFrame: 7 years
measure: To document the location of the sentinel nodes in patients with invasive cervical cancer.
timeFrame: 7 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary Gemignani, MD
role: PRINCIPAL_INVESTIGATOR
References: