Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
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
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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
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 Adenoma 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 June 17, 2013