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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00028951
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of vulvar malignancy
* Stage I-IVB
* Planned radical vulvectomy or hemivulvectomy AND
* Ipsilateral or bilateral inguinal lymphadenectomy
* Presence of groin node metastases is allowed
* No primary or secondary lymphedema of the lower extremities
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* GOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* No bleeding disorder
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Albumin at least 3.0 g/dL
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No prior lower extremity deep vein thrombosis
Other:
* No known sensitivity or anaphylaxis to bovine-derived products
* No known prior exposure to fibrin tissue adhesive
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis
* No prior fracture of any portion of either leg
* Preoperative circumferential measurements of legs must differ by less than 3 cm
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for a prior malignancy
* Concurrent adjuvant chemotherapy allowed
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for a prior malignancy
* No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity
Surgery:
* See Disease Characteristics
* No prior inguinal surgery
* No prior surgery to veins or arteries of either leg
* No other concurrent elective surgery during same operative event as inguinal lymphadenectomy
Other:
* At least 30 days since prior investigational products or devices
* At least 7 days since prior anticoagulants
* Concurrent enrollment on GOG-0173 or other adjuvant treatment protocols is allowed
* No other concurrent investigational products or devices
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00028951
Study Brief:
Protocol Section:
NCT00028951