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

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028951

Purpose

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.

Condition	Intervention	Phase
Lymphedema Perioperative/Postoperative Complications Vulvar Cancer	Drug: fibrin sealant Procedure: surgical wound closure	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Cancer Lymphedema Surgery Vulvar Cancer

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Study Start Date:	January 2003
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028951

Show 49 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jay W. Carlson, DO

Gynecologic Oncology of West Michigan

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Carlson JW, Kauderer J, Walker JL, Gold MA, O'Malley D, Tuller E, Clarke-Pearson DL. A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: A Gynecologic Oncology Group study. Gynecol Oncol. 2008 May 13; [Epub ahead of print]

Carlson J, Kauderer J, Walker J, et al.: Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-228, 2007.

Study ID Numbers:	CDR0000069149, GOG-0195, NCI-P01-0201
Study First Received:	January 4, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00028951 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lymphedema
perioperative/postoperative complications
stage I vulvar cancer

stage II vulvar cancer
stage III vulvar cancer
stage IV vulvar cancer

Additional relevant MeSH terms:

Coagulants
Fibrin Tissue Adhesive
Hematologic Agents
Genital Neoplasms, Female
Urogenital Neoplasms
Pharmacologic Actions
Hemostatics
Lymphedema
Genital Diseases, Female

Lymphatic Diseases
Neoplasms
Pathologic Processes
Neoplasms by Site
Postoperative Complications
Vulvar Neoplasms
Therapeutic Uses
Vulvar Diseases

ClinicalTrials.gov processed this record on November 27, 2009