Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma (NCT00060333) | Clinical Trial Compass
CompletedPhase 2
Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
United States20 participantsStarted 2003-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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; n…
What they're measuring
1
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence