Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients. - Full Text View

Purpose

The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women & Infants Hospital

Condition	Intervention
Vulvar Cancer	Procedure: Sentinel Node Biopsy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients With Sentinel Lymph Nodes Determined to be Negative for Metastatic Disease.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Vulvar Cancer

U.S. FDA Resources

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:

Determination of inguinal recurrence rates in patients with negative sentinel lymph node biopsy alone. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ability to detect inguinal sentinel nodes in vulvar cancer patients. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Inguinal sentinel node biopsy will be performed.

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Eligibility

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

Criteria

Inclusion Criteria:

Patient of any age 18 years or over.
Biopsy proven squamous cell carcinoma of the vulva.
Depth of invasion 1mm or greater.
Patients with groins clinically negative for nodal metastasis.
Patients that are candidates for groin dissections.

Exclusion Criteria:

Any patient below the age of 18
Patients with clinically suspicious groin nodes for metastatic disease.
Patients with non-squamous cell vulvar lesions.
Depth of invasion less than 1mm.
Patients refusing to sign an informed consent form.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315159

Locations

United States, Rhode Island
Women and Infants' Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States, 02905
Contact: Richard G Moore, MD 401-453-7520 rmoore@wihri.org
Contact: Paul A DiSilvestro, MD (401) 453-7520 pdisilvestro@wihri.org

Sponsors and Collaborators

Women and Infants Hospital of Rhode Island

Investigators

Principal Investigator:

Richard G Moore, MD

Women and Infants' Hospital

More Information

Publications:

Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.

Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ, Thun MJ. Cancer statistics, 2005. CA Cancer J Clin. 2005 Jan-Feb;55(1):10-30. Erratum in: CA Cancer J Clin. 2005 Jul-Aug;55(4):259.

Podratz KC, Symmonds RE, Taylor WF, Williams TJ. Carcinoma of the vulva: analysis of treatment and survival. Obstet Gynecol. 1983 Jan;61(1):63-74.

Hacker NF, Leuchter RS, Berek JS, Castaldo TW, Lagasse LD. Radical vulvectomy and bilateral inguinal lymphadenectomy through separate groin incisions. Obstet Gynecol. 1981 Nov;58(5):574-9.

Cabanas RM. An approach for the treatment of penile carcinoma. Cancer. 1977 Feb;39(2):456-66.

Morton DL, Wen DR, Wong JH, Economou JS, Cagle LA, Storm FK, Foshag LJ, Cochran AJ. Technical details of intraoperative lymphatic mapping for early stage melanoma. Arch Surg. 1992 Apr;127(4):392-9.

Levenback C, Burke TW, Morris M, Malpica A, Lucas KR, Gershenson DM. Potential applications of intraoperative lymphatic mapping in vulvar cancer. Gynecol Oncol. 1995 Nov;59(2):216-20.

Levenback C, Morris M, Burke TW, Gershenson DM, Wolf JK, Wharton JT. Groin dissection practices among gynecologic oncologists treating early vulvar cancer. Gynecol Oncol. 1996 Jul;62(1):73-7.

Levenback C. Intraoperative lymphatic mapping and sentinel node identification: gynecologic applications. Recent Results Cancer Res. 2000;157:150-8. Review.

Levenback C, Coleman RL, Ansink A, van der Zee AG. Re: Terada et al.: Sentinel node dissection and ultrastaging in squamous cell cancer of the vulva. Gynecol Oncol 76:40-44, 2000. Gynecol Oncol. 2000 Jun;77(3):484-5. No abstract available.

Levenback C, Coleman RL, Burke TW, Bodurka-Bevers D, Wolf JK, Gershenson DM. Intraoperative lymphatic mapping and sentinel node identification with blue dye in patients with vulvar cancer. Gynecol Oncol. 2001 Nov;83(2):276-81.

Decesare SL, Fiorica JV, Roberts WS, Reintgen D, Arango H, Hoffman MS, Puleo C, Cavanagh D. A pilot study utilizing intraoperative lymphoscintigraphy for identification of the sentinel lymph nodes in vulvar cancer. Gynecol Oncol. 1997 Sep;66(3):425-8.

Terada KY, Coel MN, Ko P, Wong JH. Combined use of intraoperative lymphatic mapping and lymphoscintigraphy in the management of squamous cell cancer of the vulva. Gynecol Oncol. 1998 Jul;70(1):65-9.

de Hullu JA, Doting E, Piers DA, Hollema H, Aalders JG, Koops HS, Boonstra H, van der Zee AG. Sentinel lymph node identification with technetium-99m-labeled nanocolloid in squamous cell cancer of the vulva. J Nucl Med. 1998 Aug;39(8):1381-5.

Echt ML, Finan MA, Hoffman MS, Kline RC, Roberts WS, Fiorica JV. Detection of sentinel lymph nodes with lymphazurin in cervical, uterine, and vulvar malignancies. South Med J. 1999 Feb;92(2):204-8.

Ansink AC, Sie-Go DM, van der Velden J, Sijmons EA, de Barros Lopes A, Monaghan JM, Kenter GG, Murdoch JB, ten Kate FJ, Heintz AP. Identification of sentinel lymph nodes in vulvar carcinoma patients with the aid of a patent blue V injection: a multicenter study. Cancer. 1999 Aug 15;86(4):652-6.

Rodier JF, Janser JC, Routiot T, David E, Ott G, Schneegans O, Ghnassia JP. Sentinel node biopsy in vulvar malignancies: a preliminary feasibility study. Oncol Rep. 1999 Nov-Dec;6(6):1249-52.

Kiss H, Ahner R, Hohlagschwandtner M, Leitich H, Husslein P. Fetal fibronectin as a predictor of term labor: a literature review. Acta Obstet Gynecol Scand. 2000 Jan;79(1):3-7. Review.

Sideri M, De Cicco C, Maggioni A, Colombo N, Bocciolone L, Trifiro G, De Nuzzo M, Mangioni C, Paganelli G. Detection of sentinel nodes by lymphoscintigraphy and gamma probe guided surgery in vulvar neoplasia. Tumori. 2000 Jul-Aug;86(4):359-63.

Molpus KL, Kelley MC, Johnson JE, Martin WH, Jones HW 3rd. Sentinel lymph node detection and microstaging in vulvar carcinoma. J Reprod Med. 2001 Oct;46(10):863-9.

Sliutz G, Reinthaller A, Lantzsch T, Mende T, Sinzinger H, Kainz C, Koelbl H. Lymphatic mapping of sentinel nodes in early vulvar cancer. Gynecol Oncol. 2002 Mar;84(3):449-52.

Hacker NF, Berek JS, Lagasse LD, Leuchter RS, Moore JG. Management of regional lymph nodes and their prognostic influence in vulvar cancer. Obstet Gynecol. 1983 Apr;61(4):408-12.

Moore RG, DePasquale SE, Steinhoff MM, Gajewski W, Steller M, Noto R, Falkenberry S. Sentinel node identification and the ability to detect metastatic tumor to inguinal lymph nodes in squamous cell cancer of the vulva. Gynecol Oncol. 2003 Jun;89(3):475-9.

Moore RG, Granai CO, Gajewski W, Gordinier M, Steinhoff MM. Pathologic evaluation of inguinal sentinel lymph nodes in vulvar cancer patients: a comparison of immunohistochemical staining versus ultrastaging with hematoxylin and eosin staining. Gynecol Oncol. 2003 Nov;91(2):378-82.

Responsible Party:	Richard Moore, MD, Women & Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:	NCT00315159 History of Changes
Other Study ID Numbers:	03-0031
Study First Received:	April 13, 2006
Last Updated:	February 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:

Squamous
Cell
Carcinoma
Vulva
Sentinel Node

Additional relevant MeSH terms:

Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013