Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
18 Years
N/A
Female
Long-term Effects Secondary to Cancer Therapy in Adults, Vulvar Cancer
Trial Information
Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
OBJECTIVES:
- To investigate the safety of replacing complete inguinofemoral lymphadenectomy by
adjuvant radiotherapy in early-stage vulvar cancer patients with a sentinel node
metastasis ≤ 2 mm.
- To evaluate the short- and long-term morbidity associated with the sentinel lymph node
procedure and adjuvant (chemo)radiotherapy.
- To further establish the safety of omitting complete inguinofemoral lymphadenectomy in
patients with a negative sentinel node.
- To explore the efficacy, safety, and short- and long-term morbidity of inguinofemoral
lymphadenectomy and radiotherapy in patients with sentinel node metastasis > 2 mm.
(exploratory)
OUTLINE: This is a multicenter study.
Patients undergo planned radical vulvectomy and sentinel lymph node dissection. Patients
without lymph node involvement undergo observation. Patients with minimal lymph node
involvement undergo radiotherapy. Patients with significant lymph node involvement undergo
inguinofemoral lymphadenectomy and radiotherapy with or without chemotherapy according to
institutional guidelines.
After completion of study treatment, patients are followed up every 2 months for 2 years.
Follow-up includes interview, gynecological examination, and palpation of the groins.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Patients with squamous cell carcinoma, depth of invasion > 1 mm
- Patients with T1 or T2 tumors (International Federation of Gynecology and Obstetrics
[FIGO] staging), tumors < 4 cm, and/or not encroaching in urethra, vagina, or anus
with clinically negative inguinofemoral lymph nodes
- Localization 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
- No inoperable tumors and tumors with diameter > 4 cm
- No 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
- No patients with multifocal tumors
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Patients who are currently on an investigational drug for the treatment of vulvar
cancer are excluded from participation in this trial
- No concurrent intensity-modulated radiation therapy
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy
Safety Issue:
No
Principal Investigator
Brian Slomovitz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Authority:
Unspecified
Study ID:
CDR0000721346
NCT ID:
NCT01500512
Start Date:
February 2012
Completion Date:
Related Keywords:
- Long-term Effects Secondary to Cancer Therapy in Adults
- Vulvar Cancer
- long-term effects secondary to cancer therapy in adults
- squamous cell carcinoma of the vulva
- stage IA vulvar cancer
- stage IB vulvar cancer
- stage II vulvar cancer
- Vulvar Neoplasms
Name | Location |
|---|---|
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
| Women's Cancer Center - La Canada | Las Vegas, Nevada 89169 |
