Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

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Brief Title

Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

Official Title

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

Brief Summary

      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.

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.

Study Type

Observational

Primary Outcome

Safety of sentinel lymph node dissection

Condition

Stage I Vulvar Cancer

Intervention

Clinical Observation

Study Arms / Comparison Groups

 Observation (observe patients undergoing SLN dissection)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

148

Start Date

January 3, 2012

Primary Completion Date

July 1, 2015

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Brian Slomovitz, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT01500512

Organization ID

GOG-0270

Secondary IDs

NCI-2012-00100

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Brian Slomovitz, Principal Investigator, NRG Oncology

Verification Date

August 2017