Back to resultsIntra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
Primary Purpose
Cervical Cancer, Endometrial Cancer, Cervical Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lymphatic Mapping
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring Cervix, Endometrium, Cervical Carcinoma, Lymphatic Mapping
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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.
Secondary Outcome Measures
To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
To document the location of the sentinel nodes in patients with invasive cervical cancer.
Full Information
NCT ID
NCT00595725
First Posted
January 7, 2008
Last Updated
September 7, 2011
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00595725
Brief Title
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Cervical Carcinoma
Keywords
Cervix, Endometrium, Cervical Carcinoma, Lymphatic Mapping
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lymphatic Mapping
Intervention Description
Intra-Operative Lymphatic Mapping
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
Time Frame
7 years
Title
To document the location of the sentinel nodes in patients with invasive cervical cancer.
Time Frame
7 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Gemignani, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
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