Observational study on vulvar cancer

January 03, 2012
314466
Cancer, Cancer-Gynecologic
Tashanna Myers, MD
  • D’Amour Center for Cancer Care, 3350 Main Street , Springfield, MA
  • Baystate Franklin Medical Center, 164 High Street, Greenfield, MA
To investigate the safety of replacing complete inguino femoral lymphadenectomy by adjuvant radiotherapy in early stage vulvar cancer patients with a sentinel node metastasis < or = 2 mm.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Inclusion Criteria:
• Patients must have squamous cell carcinoma with a depth invasion > 1 mm
• Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
• Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible
• Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes
• Patients must sign informed consent

Exclusion Criteria:
• Inoperable tumors with diameter > 4 cm
• Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
• Patients with multifocal tumors
• Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial

Active
Observational
Laura Sorci
413-794-3188