Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01406769
Eligibility Criteria:
Inclusion Criteria:
* Patients with vulvar cancer already enrolled onto Gynecologic Oncology Group (GOG)-0244 who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will receive a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy;
* Patients who are going to receive multi-modality therapy (radiation +/- chemotherapy) after undergoing surgery are eligible
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information for GOG-0269 and for GOG-0244
* Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy during the same operative event
* Serum Albumin level of \>= 3.0 within 14 days of entry
* Patients with a GOG performance status of 0, 1, or 2
Exclusion Criteria:
* Patients not enrolled onto GOG-0244
* Patients with any prior clinical history of lower extremity lymphedema
* Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
* Patients with a prior history of chronic lower extremity swelling
* Patients with a GOG Performance Grade of 3 or 4
* Patients with a history of other invasive malignancies if that malignancy included a bilateral lymph node procedure (example: bilateral mastectomies and axillary lymphadenectomies) or if their previous cancer treatment included any of the surgical procedures
* Patients who have had prior lower extremity vascular surgery (arterial or venous)
* Patients who have had prior pelvic bilateral axillary or any pelvic, abdominal, inguinal, or lower extremity radiation therapy
* Patients who are going to receive another elective surgery during the same operative event as their inguinal lymphadenectomy and vulvar surgery
* Patients who undergo sentinel node biopsy without the intention of undergoing a complete lymphadenectomy during that same operative event
* Patients with an implanted cardiac device such as a pacemaker or implantable cardioverter defibrillator
* Patients who are pregnant or currently breastfeeding
* Patients who have been treated for, or are at risk of, bilateral arm lymphedema
* Patients with an allergic reaction to electrocardiogram (EKG) electrodes
* Patients who have had bilateral auxiliary dissection
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01406769
Study Brief:
Protocol Section:
NCT01406769