NCT00060333

Adjuvant Radiation Therapy in Treating Patients With Resected Desmoplastic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Melanoma

Interventions

Type	Name	Description
RADIATION	radiation therapy

Timeline

• Start date: 2003-07-01
• Primary completion: 2011-06-01
• Completion: 2016-04-01
• First posted: 2003-05-07
• Last updated: 2017-03-17
• Results posted: 2017-03-17

Locations

39 sites across 1 country: United States