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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

December 24, 2011
October 26, 2016
January 2012
July 2015   (final data collection date for primary outcome measure)
Safety of sentinel lymph node dissection [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy [ Designated as safety issue: No ]
  • Short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo)radiotherapy [ Designated as safety issue: No ]
  • Safety of omitting complete inguinofemoral lymphadenectomy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01500512 on ClinicalTrials.gov Archive Site
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Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
  • 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
Undergo observation
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.
Intervention: Other: Clinical Observation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
144
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July 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01500512
GOG-0270, NCI-2012-00100, CDR0000721346, GOG-0270, GOG-0270, GOG-0270, U10CA180868, U10CA027469
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Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Brian Slomovitz NRG Oncology
Gynecologic Oncology Group
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP