Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent Melanoma
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 20
- Locations
- 39
- Primary Endpoint
- 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
Time Frame: 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 Outcomes
- Incidence of Regional and Systemic Metastases(Up to 5 years)
- Failure Time(Time from randomization to death due to any cause or disease progression (up to 5 years))
- Toxicity(Up to 5 years)
- Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory(Baseline to up to 3 months)
- Survival Time(up to 5 years)