A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Malignant Mesothelioma
- Sponsor
- University of Glasgow
- Enrollment
- 44
- Locations
- 3
- Primary Endpoint
- Incidence of metastatic skin nodules
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.
Detailed Description
OBJECTIVES: * Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma. * Determine whether the nodules that develop after radiotherapy are symptomatic in these patients. * Compare the quality of life of patients treated with radiotherapy vs standard care alone. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed. * Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months. Patients are followed at 1, 2, 4, 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of metastatic skin nodules