CompletedPhase 3

Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

United StatesStarted 2003-01

Plain-language summary

RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is effective in decreasing lymphedema following surgery to remove lymph nodes. PURPOSE: Randomized phase III trial to determine the effectiveness of fibrin sealant in reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of the vulva.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Trial details

NCT IDNCT00028951

SponsorGynecologic Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2005-12

View on ClinicalTrials.gov More Lymphedema trials