Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

PRIMARY OBJECTIVES:

I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) >= 1 mm deep
treated with adjuvant radiotherapy after surgical resection.

II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant
radiotherapy after surgical resection.

SECONDARY OBJECTIVES:

I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease
free and overall survival.

II. Evaluate the immediate and long-term morbidity of the addition of radiotherapy to
surgery.

OUTLINE:

Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly
over approximately 2.5 weeks for a total of 5 fractions in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

- Pathologically proven DM >= 1 mm in depth or locally recurrent DM; recurrent tumor is
defined as a tumor found =< 2 cm from the previous excision or within the surgical
bed (which includes the extent of previous skin flaps)

- DM resected with pathologically negative margins; acceptable surgery includes
standard wide local excision and Moh's surgery

- Tumors on the trunk proximal extremities need to have a >= 2 cm negative margin;
tumors located on the head and neck and distal extremities will have an attempt
at 2 cm negative margins but due to location and subsequent concern regarding
cosmesis a margin < 2 cm will be acceptable if margin is negative

- Margins from tumors resected using the Moh's technique will be accepted if
negative and best approximation of tumor width will be made

- Radiation therapy (RT) is to begin =< 8 weeks after definitive surgical resection

- Adjuvant systemic therapy (immunotherapy or chemotherapy) must be postponed until
irradiation is completed

Exclusion Criteria

- Previous irradiation to the same site

- Non-healing surgical wound

- Active infection at the surgical site

- Evidence of metastatic disease; local nodal disease is still eligible for the trial

- Life expectancy < 1 year

- Melanoma with focally desmoplastic features, in which the desmoplastic melanoma is
not the predominant histologic pattern of the tumor, will be excluded;
non-desmoplastic neurotropic melanoma and non-desmoplastic spindle cell melanoma are
also excluded

- Previous malignancy < 5 years excluding basal cell carcinoma or squamous cell
carcinoma of the skin or cervical carcinoma in situ (with the exception of patients
who have stage I breast cancer who were adequately treated with adjuvant therapy and
are currently disease free, and patients with stage I or II prostate cancer treated
with prostatectomy or radiotherapy and are biochemically free of disease [for radical
retropubic prostatectomy (RRP) prostate-specific antigen (PSA) < 0.3 and for
radiotherapy PSA < 2.0 above the post treatment nadir])

- Any of the following:

- Pregnant women

- Women of childbearing potential who are unwilling to employ adequate
contraception (condoms, diaphragm, birth control pills, injections, intrauterine
device [IUD], surgical sterilization, abstinence, etc.)