Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.
PURPOSE: This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma|
- Incidence of local recurrence 2 years after completion of study treatment [ Designated as safety issue: No ]
- Incidence of regional and systemic metastases [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Failure time [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Fatigue as assessed by the Brief Fatigue Inventory [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
- Determine the recurrence rates of patients with desmoplastic melanoma treated with adjuvant radiotherapy after surgical resection.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the immediate and long-term morbidity of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Within 8 weeks after surgical resection, patients undergo radiotherapy twice weekly over 2.5 weeks in the absence of unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Show 39 Study Locations
|Study Chair:||Barbara A. Pockaj, MD||Mayo Clinic Hospital|
|Investigator:||John H. Donohue, MD||Mayo Clinic|
|Investigator:||Jan L. Kasperbauer, MD||Mayo Clinic|