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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:
ClinicalTrials.gov Identifier:
NCT01500512
First Posted: December 28, 2011
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  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
Stage I Vulvar Cancer Stage II Vulvar Cancer Stage III Vulvar Cancer Vulvar Squamous Cell Carcinoma Other: Clinical Observation

Study Type: Observational
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 ]

Enrollment: 148
Actual Study Start Date: January 3, 2012
Primary Completion Date: July 1, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721346
GOG-0270 ( Other Identifier: NRG Oncology )
GOG-0270 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 24, 2011
First Posted: December 28, 2011
Last Update Posted: August 24, 2017
Last Verified: August 2017

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