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LymphedemaPhase 3NCT00028951

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

A Phase 3 study testing fibrin sealant and surgical wound closure in people with Lymphedema and Perioperative/Postoperative Complications, run by Gynecologic Oncology Group at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
fibrin sealant and surgical wound closure
Type of treatment
Surgery or procedure
How many people
Not given
Where
49 sitesUnited States
Study dates
Jan 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

    Burlington, Vermont, 05401

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7570

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0520

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44124

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Central Illinois

    Decatur, Illinois, 62794-9640

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1740

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-2516

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73190

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905-0001

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11790-7775

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
fibrin sealant, surgical wound closure
Keywords
lymphedema, perioperative/postoperative complications, stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer
Medical subject headings
Lymphedema, Postoperative Complications, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fibrin sealantDrug

  • surgical wound closureProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028951
Sponsor's protocol ID
CDR0000069149
Other IDs
GOG-0195, NCI-P01-0201
Status last verified
Dec 2005
First submitted
4 Jan 2002
Last updated
9 Jul 2013
Results posted
No

Publications

  • Carlson JW, Kauderer J, Walker JL, Gold MA, O'Malley D, Tuller E, Clarke-Pearson DL; Gynecologic Oncology Group. 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 Jul;110(1):76-82. doi: 10.1016/j.ygyno.2008.03.005. Epub 2008 May 15.

    PubMed 18482765

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fibrin sealant and surgical wound closure in people with Lymphedema and Perioperative/Postoperative Complications, run by Gynecologic Oncology Group at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028951, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.

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