GOG-270: GROningen INternational Study on Sentinel nodes in Vulvar cancer(GROINSS-V) II: An Observational Study

Study ID
STU 012014-083

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Zale Lipshy University Hospital

Contact
Annette Paulsen
214/648-2290
ANNETTE.PAULSEN@UTSouthwestern.edu

Principal Investigator
David Miller

Summary

a prospective observational study will be performed in patients with early stage SCC (diameter [Less Than] 4cm) of the vulva without suspicious lymph nodes at palpation or radiology and planned for surgery (radical local excision or radical vulvectomy in combination with sentinel node procedure).

in order to ensure the quality of the sentinel node procedure in the participating centers the following criteria have been formulated: a) centers with no further experience in sentinel node detection: the sentinel node procedure with subsequent full lymphadenectomy has to be performed successfully in at least 10 vulvar cancer patients. Documented data of these patients should be available for the study coordinator, b) centers with large experience in other sites (breast / melanomas), but not having gynecologists with experience: the sentinel node procedure with subsequent full lymphadenectomy has to be performed successfully in at least 5 vulvar cancer patients. Documented data of these patients should be available for the study coordinator, c) centers with gynecologists with large experience in other sites (breast/melanomas): no further experience in vulvar cancer needed.

When the study coordinator has approved the data obtained in the first 10 or 5 patients or otherwise has ensured the quality of the sentinel node experience, a center will be allowed to participate in the trial. a Quality assurance procedure will take place among the participant investigators to educate participating investigators conduct conforming sentinel node procedure with appropriate documentaion.

Patients are informed about the operation and will receive a patient information form. Preoperatively all patients will have imaging of their groins.

Participant Eligibility

- Patients with squamous cell carcinoma, depth of invasion > 1 mm.
- Patients with T1 or T2 tumors (FIGO staging) tumors < 4 cm, not encroaching in urethra, vagina or
anus with clinically negative inguinofemoral lymph nodes.
- Localisation and size of the tumor are such that perilesional injection of the tracers at three or
four sites is possible.
- Preoperative imaging do not show enlarged (< 1.5 cm) / suspicious nodes
- Possibility to obtain informed consent