Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Completed · Phase 2

Conditions studied: Recurrent Melanoma

In brief

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.

Key facts

Study ID

NCT00060333

Run by

Alliance for Clinical Trials in Oncology

People needed

20

Starts

2003-07-01

Expected to finish

2016-04-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• Mercy Capitol Hospital — Des Moines, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at John Stoddard Cancer Center — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates at Mercy Cancer Center — Des Moines, Iowa, United States
• Mercy Cancer Center at Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Lutheran Hospital — Des Moines, Iowa, United States
• McCreery Cancer Center at Ottumwa Regional — Ottumwa, Iowa, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
• St. Luke's Regional Medical Center — Sioux City, Iowa, United States
• Fairview Ridges Hospital — Burnsville, Minnesota, United States
• Mercy and Unity Cancer Center at Mercy Hospital — Coon Rapids, Minnesota, United States
• Fairview Southdale Hospital — Edina, Minnesota, United States
• Mercy and Unity Cancer Center at Unity Hospital — Fridley, Minnesota, United States
• Minnesota Oncology Hematology, PA - Maplewood — Maplewood, Minnesota, United States
• Virginia Piper Cancer Institute at Abbott - Northwestern Hospital — Minneapolis, Minnesota, United States
• Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center — Robbinsdale, Minnesota, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• Park Nicollet Cancer Center — Saint Louis Park, Minnesota, United States
• United Hospital — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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