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Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection (GROINSS-V)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01500512
First received: December 24, 2011
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.

Condition Intervention
Long-Term Effects Secondary to Cancer Therapy in Adults
Stage I Vulvar Cancer
Stage II Vulvar Cancer
Stage III Vulvar Cancer
Vulvar Squamous Cell Carcinoma
Other: Clinical Observation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Safety of sentinel lymph node dissection [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 144
Study Start Date: January 2012
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation (observe patients undergoing SLN dissection)
Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.
Other: Clinical Observation
Undergo observation

Detailed Description:

PRIMARY OBJECTIVES:

I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure.

OUTLINE:

Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500512

  Show 37 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brian Slomovitz NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01500512     History of Changes
Other Study ID Numbers: GOG-0270  NCI-2012-00100  CDR0000721346  GOG-0270  GOG-0270  U10CA180868  U10CA027469 
Study First Received: December 24, 2011
Last Updated: October 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Vulvar Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 09, 2016