Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
Condition: Recurrent Melanoma
MeSH terms: Melanoma
Intervention: radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent melanoma; stage I melanoma; stage II melanoma; stage III 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.
    

Eligibility criteria:

        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.)