Brief Title
Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
Official Title
A Phase III Clinical Trial Use of TISSEEL VH Fibrin Sealant to Reduce Lymphedema Incidence After Inguinal Lymph Node Dissection Performed in the Management of Vulvar Malignancies
Brief 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.
Detailed Description
OBJECTIVES:
- Compare the incidence of lymphedema of the lower extremity after lymph node dissection
in patients with vulvar malignancies treated with fibrin sealant vs standard care.
- Compare the frequency of surgical complications in patients treated with fibrin sealant
vs standard care.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive
fibrin sealant to surgical site.
- Arm II: After surgery, patients receive standard care for closure of surgical site.
Lymphedema is assessed at time of drain removal, at week 6, and then at months 3 and 6.
Patients are followed at week 6 and at months 3 and 6.
PROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for
this study within 2 years.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Secondary Outcome
Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Condition
Lymphedema
Intervention
fibrin sealant
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
Drug
Start Date
January 2003
Primary Completion Date
December 2005
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jay W. Carlson, DO, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00028951
Organization ID
CDR0000069149
Secondary IDs
GOG-0195
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Jay W. Carlson, DO, Study Chair, Gynecologic Oncology of West Michigan
Verification Date
December 2005