Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Wide local excision of the primary tumor, whenever possible, and regional lymph node dissection have been recommended for patients with stage II Merkel cell carcinoma (MCC).[1,2][Level of evidence: 3iiiDiii] Because of the aggressive nature of MCC and the high incidence of locoregional recurrence after surgery alone, many authors advocate adjuvant radiation therapy to the primary site and to the regional lymph node basin.[1-4] Convincing data from prospective trials are not available; based on retrospective reviews, however, radiation therapy has been used in patients with larger tumors, tumors with lymphatic invasion, tumors approaching the surgical margins of resection, and locally unresectable tumors. Improved locoregional control has been achieved with resection followed by radiation therapy as compared with surgery alone in some retrospective nonrandomized reports.[5] Studies suggest that the appropriate total dose is about 50 Gy to the surgical bed and the draining regional lymphatics, delivered in 2 Gy fractions.[1,2,4-6] For patients with unresected tumors or tumors with microscopic evidence of spread beyond resected margins, higher doses of 56 Gy to 65 Gy have been recommended.[1][Level of evidence: 3iiiDiii]

The role of adjuvant chemotherapy remains unproven but is advocated by some authors.[1,6,7] Studies have shown response rates in the range of 60% in the setting of locally advanced or metastatic disease using chemotherapy regimens similar to those used for patients with small cell lung cancer.[5] (See the PDQ summary on Small Cell Lung Cancer Treatment for chemotherapeutic options.) The benefit of chemotherapy as adjuvant therapy is yet to be determined.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II neuroendocrine carcinoma of the skin. 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. Haag ML, Glass LF, Fenske NA: Merkel cell carcinoma. Diagnosis and treatment. Dermatol Surg 21 (8): 669-83, 1995.  [PUBMED Abstract]
   
   
2. Yiengpruksawan A, Coit DG, Thaler HT, et al.: Merkel cell carcinoma. Prognosis and management. Arch Surg 126 (12): 1514-9, 1991.  [PUBMED Abstract]
   
   
3. Goepfert H, Remmler D, Silva E, et al.: Merkel cell carcinoma (endocrine carcinoma of the skin) of the head and neck. Arch Otolaryngol 110 (11): 707-12, 1984.  [PUBMED Abstract]
   
   
4. Marks ME, Kim RY, Salter MM: Radiotherapy as an adjunct in the management of Merkel cell carcinoma. Cancer 65 (1): 60-4, 1990.  [PUBMED Abstract]
   
   
5. Goessling W, McKee PH, Mayer RJ: Merkel cell carcinoma. J Clin Oncol 20 (2): 588-98, 2002.  [PUBMED Abstract]
   
   
6. Tai PT, Yu E, Winquist E, et al.: Chemotherapy in neuroendocrine/Merkel cell carcinoma of the skin: case series and review of 204 cases. J Clin Oncol 18 (12): 2493-9, 2000.  [PUBMED Abstract]
   
   
7. Feun LG, Savaraj N, Legha SS, et al.: Chemotherapy for metastatic Merkel cell carcinoma. Review of the M.D. Anderson Hospital's experience. Cancer 62 (4): 683-5, 1988.  [PUBMED Abstract]
   
   

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