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Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Long-term Effects Secondary to Cancer Therapy in Adults, Vulvar Cancer

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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 CareSpringfield, Massachusetts  01199
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169