Current Clinical Trials

Radical vulvectomy has been associated with 5-year survival rates in excess of 90%. The choice of treatment depends on various tumor and patient factors.

Standard treatment options:

1. For microinvasive lesions (<1 mm invasion) with no associated severe vulvar dystrophy, a wide (5–10 mm) excision is indicated. 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 should be performed.[1] Candidates for this procedure should have lesions 2 cm or less in diameter with 5 mm or less invasion, no capillary lymphatic space invasion, and clinically uninvolved nodes.[2] A literature review suggests that the local recurrence rate is 7.2% after radical local excision compared with 6.3% after radical vulvectomy.[3]



2. Radical vulvectomy with bilateral inguinal and femoral node dissection. The morbidity of this operation can be reduced by using separate groin incisions and unilateral or superficial lymphadenectomy for select early lesions.[4] Also, the definition of radical vulvectomy is being extended with the realization that the effect of radical surgery is limited by the closest resection margin rather than the achievement of total organ ablation.[5] One study suggested that the margin of clearance of the tumor is the best predictor of local recurrence. All of the recurrences were with surgically free margins less than 8 mm.[6]

   In a Gynecologic Oncology Group (GOG) randomized trial, radiation therapy to the groin for patients with clinical N0 disease led to an inferior survival secondary to an increased groin failure rate compared with groin dissection and adjuvant radiation therapy for positive groin nodes.[7] Unfortunately, because the clinical trial was poorly designed with regard to adequacy of dose at the depth of the groin nodes, the question of whether elective nodal radiation therapy has a better outcome than groin dissection was not satisfactorily answered. A retrospective study with similar patient numbers and superior radiation therapy design contradicts the GOG data and reports no significant survival advantage to groin dissection versus radiation therapy to the groin.[8] Therefore, radiation therapy to the groin for patients with clinical N0 disease is an alternative to groin dissection for women who refuse or are deemed medically unfit to withstand groin dissections.




3. For those few patients unable to tolerate radical vulvectomy or deemed unsuitable for surgery because of site or extent of disease, radical radiation therapy may result in long-term survival.[8-11]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry 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.

References

1. Malfetano JH, Piver MS, Tsukada Y, et al.: Univariate and multivariate analyses of 5-year survival, recurrence, and inguinal node metastases in stage I and II vulvar carcinoma. J Surg Oncol 30 (2): 124-31, 1985.  [PUBMED Abstract]
   
   
2. 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.  [PUBMED Abstract]
   
   
3. Hacker NF, Van der Velden J: Conservative management of early vulvar cancer. Cancer 71 (4 Suppl): 1673-7, 1993.  [PUBMED Abstract]
   
   
4. Hoffman MS, Roberts WS, Lapolla JP, et al.: Recent modifications in the treatment of invasive squamous cell carcinoma of the vulva. Obstet Gynecol Surv 44 (4): 227-33, 1989.  [PUBMED Abstract]
   
   
5. Thomas GM, Dembo AJ, Bryson SC, et al.: Changing concepts in the management of vulvar cancer. Gynecol Oncol 42 (1): 9-21, 1991.  [PUBMED Abstract]
   
   
6. Heaps JM, Fu YS, Montz FJ, et al.: Surgical-pathologic variables predictive of local recurrence in squamous cell carcinoma of the vulva. Gynecol Oncol 38 (3): 309-14, 1990.  [PUBMED Abstract]
   
   
7. Stehman FB, Bundy BN, Thomas G, et al.: Groin dissection versus groin radiation in carcinoma of the vulva: a Gynecologic Oncology Group study. Int J Radiat Oncol Biol Phys 24 (2): 389-96, 1992.  [PUBMED Abstract]
   
   
8. Petereit DG, Mehta MP, Buchler DA, et al.: Inguinofemoral radiation of N0,N1 vulvar cancer may be equivalent to lymphadenectomy if proper radiation technique is used. Int J Radiat Oncol Biol Phys 27 (4): 963-7, 1993.  [PUBMED Abstract]
   
   
9. Slevin NJ, Pointon RC: Radical radiotherapy for carcinoma of the vulva. Br J Radiol 62 (734): 145-7, 1989.  [PUBMED Abstract]
   
   
10. Perez CA, Grigsby PW, Galakatos A, et al.: Radiation therapy in management of carcinoma of the vulva with emphasis on conservation therapy. Cancer 71 (11): 3707-16, 1993.  [PUBMED Abstract]
    
    
11. Kumar PP, Good RR, Scott JC: Techniques for management of vulvar cancer by irradiation alone. Radiat Med 6 (4): 185-91, 1988 Jul-Aug.  [PUBMED Abstract]
    
    

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