Trials / Unknown
UnknownNCT01500512
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 148 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Clinical Observation | Undergo observation |
Timeline
- Start date
- 2012-01-03
- Primary completion
- 2022-07-01
- First posted
- 2011-12-28
- Last updated
- 2021-09-30
Locations
37 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01500512. Inclusion in this directory is not an endorsement.