Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

Recurrent Melanoma Clinical Trial

Official title: Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma

• NCT number: NCT00060333
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2003