Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Phase 2

Completed

Conditions: Recurrent Melanoma

Registration Number: NCT00060333

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed Description: PRIMARY OBJECTIVES:

I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) \>= 1 mm deep treated with adjuvant radiotherapy after surgical resection.

II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant radiotherapy after surgical resection.

SECONDARY OBJECTIVES:

I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease free and overall survival.

II. Evaluate the immediate and long-term morbidity of the addition of radiotherapy to surgery.

OUTLINE:

Within 8 weeks after surgical resection, patients undergo radiation therapy twice weekly over approximately 2.5 weeks for a total of 5 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence	Within 2 years after treatment	The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.

Secondary Outcome Measures

Name	Time	Method
Incidence of Regional and Systemic Metastases	Up to 5 years	Incidence of regional and systemic metastasis: Incidences will be calculated for each cohort and 95% confidence intervals will be constructed using the properties of the binomial distribution.
Failure Time	Time from randomization to death due to any cause or disease progression (up to 5 years)	Failure time is defined as the time from randomization to death due to any cause or disease progression. The median failure time will be estimated using the method of Kaplan-Meier.
Toxicity	Up to 5 years	For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. The number of participants reporting a grade 3 or higher toxicity are reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.
Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory	Baseline to up to 3 months	Fatigue Assessment: A portion of the Brief Fatigue Inventory will be used to determine fatigue changes throughout the course of radiation. Patients will fill out the questionnaire at baseline, weekly during radiation, and 3 months after the beginning of radiation. Fatigue will be defined as: minor if the patient answers 0-3 (on a 10 point scale), mild for answers of 4-6, and severe for answers of 7-10. The percentage of patients that have worsened (improved) fatigue from baseline to the radiation stage will be calculated. We will also compare fatigue levels at baseline to the 3 month visit. Worsened fatigue is defined as going from minor to mild, minor to severe, or mild to severe. Improved fatigue is defined as going from severe to mild, severe to minor, or mild to minor.
Survival Time	up to 5 years	Survival time: Survival time is defined as the time from randomization to death due to any cause. The median survival time will be estimated using the method of Kaplan-Meier.

Trial Locations

Locations (39): Mayo Clinic Scottsdale
🇺🇸
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Joliet Oncology-Hematology Associates, Limited - West
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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
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Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States