Patient case: 64-year-old female with melanoma; genetic feature: BRAF (E586K)

Clinical trial: Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Summary: This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.

Detailed description: 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.

Eligibility: 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.)

Relevance to patient case: not relevant