The PDQ editorial boards use a ranking system of levels of evidence to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. For any given therapy, results of prevention and treatment studies can be ranked on each of the following two scales:
Strength of the study design.
Strength of the endpoints.
Together, the two rankings provide a measure of the overall level of evidence. Screening studies are ranked on strength of study design alone...
A wide (1 cm margin) excision (without lymph node dissection) for microinvasive lesions (<1 mm invasion) with no associated severe vulvar dystrophy. For all other stage I lesions, if well lateralized, without diffuse severe dystrophy, and with clinically negative nodes, a radical local excision with complete unilateral lymphadenectomy. Candidates for this procedure should have lesions 2 cm or smaller in diameter with 5 mm or less invasion, no capillary lymphatic space invasion, and clinically uninvolved nodes.[2,3]
Radical local excision with ipsilateral or bilateral inguinal and femoral node dissection. In tumor clinically confined to the vulva or perineum, radical local excision with a margin of at least 1 cm has generally replaced radical vulvectomy; separate incision has replaced en bloc inguinal node dissection, ipsilateral inguinal node dissection has replaced bilateral dissection for laterally localized tumors; and femoral lymph node dissection has been omitted in many cases.[4,5,6,7]
Radical local excision and sentinel node dissection, reserving groin dissection for those with metastasis to the sentinel node(s).
Some investigators recommend radical excision and groin nodal radiation therapy as a means to avoid the morbidity of lymph node dissection. However, it is not clear whether radiation therapy can achieve the same local control rates or survival rates as lymph node dissection in early-stage disease. A randomized trial to address this issue in patients with clinically localized vulvar disease was stopped early as a result of early emergence of worse outcomes in the radiation therapy arm.[9,10] (Refer to the Role of Radiation Therapy section of this summary for more information.)
Radical radiation therapy for patients unable to tolerate surgery or deemed unsuitable for surgery because of site or extent of disease.[11,12,13,14]
Current Clinical Trials
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage I vulvar cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
General information about clinical trials is also available from the NCI Web site.
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Stehman FB, Bundy BN, Dvoretsky PM, et al.: Early stage I carcinoma of the vulva treated with ipsilateral superficial inguinal lymphadenectomy and modified radical hemivulvectomy: a prospective study of the Gynecologic Oncology Group. Obstet Gynecol 79 (4): 490-7, 1992.
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