Current Clinical Trials

In a randomized trial from the Gynecologic Oncology Group (GOG), patients with two or more pathologically positive groin nodes had significantly better survival with radiation therapy to the pelvis than with pelvic node dissection.[1] Patients in both arms of the trial received radical vulvectomy and bilateral superficial and deep groin node dissections. Patterns of failure have shown a significant decrease in groin failure with radiation therapy to the groin and pelvis compared with pelvic node dissection.

Standard treatment options:

1. Radical vulvectomy and pelvic exenteration.



2. Surgery followed by radiation therapy to the vulva for large resected lesions with narrow margins. Localized adjuvant radiation therapy consisting of 45 Gy to 50 Gy may also be indicated when there is capillary-lymphatic space invasion and thickness greater than 5 mm, particularly if the nodes are involved.[2] Radiation therapy to the pelvis and groin should be performed if two or more groin nodes are involved.[1]



3. Radiation therapy of large primary lesions to improve operability followed by radical surgery.[3,4] A radiation dose of up to 55 Gy with concomitant fluorouracil (5-FU) has been suggested.[2]



4. For those patients unable to tolerate radical vulvectomy or who are deemed unsuitable for surgery because of site or extent of disease, radical radiation therapy may result in long-term survival.[5,6] Where radiation therapy is being tested for primary definitive treatment of vulvar cancer, some prefer to add concurrent 5-FU or 5-FU and cisplatin.[2,7-10] The GOG is investigating the feasibility of preoperative chemotherapy plus radiation therapy given as a neoadjuvant to surgery for advanced vulvar cancer.[11] Four phase II trials of concurrent 5-FU with or without cisplatin with radiation therapy resulted in complete response rates of 53% to 89% for primary unresectable disease or for those who would require exenterative surgery.[7-10] With a median follow-up of 37 months, two series report crude disease-free survival rates of 47% to 84%.[7-10] Radiation complications of late fibrosis, atrophy, telangiectasia, and necrosis are minimized if the radiation fraction size is less than or equal to 1.8 Gy and excessive total doses are not used.[2,7-10] Doses of at least 54 Gy but less than 65 Gy should be used.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage IV vulvar cancer ¹. 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 ².

References

1. Homesley HD, Bundy BN, Sedlis A, et al.: Radiation therapy versus pelvic node resection for carcinoma of the vulva with positive groin nodes. Obstet Gynecol 68 (6): 733-40, 1986.  [PUBMED Abstract]
   
   
2. 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]
   
   
3. Boronow RC, Hickman BT, Reagan MT, et al.: Combined therapy as an alternative to exenteration for locally advanced vulvovaginal cancer. II. Results, complications, and dosimetric and surgical considerations. Am J Clin Oncol 10 (2): 171-81, 1987.  [PUBMED Abstract]
   
   
4. Anderson JM, Cassady JR, Shimm DS, et al.: Vulvar carcinoma. Int J Radiat Oncol Biol Phys 32 (5): 1351-7, 1995.  [PUBMED Abstract]
   
   
5. Slevin NJ, Pointon RC: Radical radiotherapy for carcinoma of the vulva. Br J Radiol 62 (734): 145-7, 1989.  [PUBMED Abstract]
   
   
6. 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]
   
   
7. Russell AH, Mesic JB, Scudder SA, et al.: Synchronous radiation and cytotoxic chemotherapy for locally advanced or recurrent squamous cancer of the vulva. Gynecol Oncol 47 (1): 14-20, 1992.  [PUBMED Abstract]
   
   
8. Berek JS, Heaps JM, Fu YS, et al.: Concurrent cisplatin and 5-fluorouracil chemotherapy and radiation therapy for advanced-stage squamous carcinoma of the vulva. Gynecol Oncol 42 (3): 197-201, 1991.  [PUBMED Abstract]
   
   
9. Koh WJ, Wallace HJ 3rd, Greer BE, et al.: Combined radiotherapy and chemotherapy in the management of local-regionally advanced vulvar cancer. Int J Radiat Oncol Biol Phys 26 (5): 809-16, 1993.  [PUBMED Abstract]
   
   
10. Thomas G, Dembo A, DePetrillo A, et al.: Concurrent radiation and chemotherapy in vulvar carcinoma. Gynecol Oncol 34 (3): 263-7, 1989.  [PUBMED Abstract]
    
    
11. Keys H: Gynecologic Oncology Group randomized trials of combined technique therapy for vulvar cancer. Cancer 71 (4 Suppl): 1691-6, 1993.  [PUBMED Abstract]