Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	Over 18	NCI	GOG-0195 NCI-P01-0201, NCT00028951

Objectives

1. 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.
2. Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care.

Entry 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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 100,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• 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

Expected Enrollment

A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.

Outcomes

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

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

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.

Carlson JW, Kauderer J, Walker JL, et al.: A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. Gynecol Oncol 110 (1): 76-82, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Jay Carlson, DO, Protocol chair		Ph: 616-957-3398 Email: jaycarlson1@mac.com

Registry Information
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
Trial Start Date		2003-01-09
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00028951
Date Submitted to PDQ		2001-11-13
Information Last Verified		2005-12-06
NCI Grant/Contract Number		U10-CA27469

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