Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Sponsored by Alliance for Clinical Trials in Oncology

About this trial

Last updated 9 years ago

Study ID

NCCTG-N0275

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

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.)