NCT00006231

Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma

A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Mesothelioma
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	quality-of-life assessment
PROCEDURE	standard follow-up care
RADIATION	radiation therapy

Timeline

• Start date: 1998-02-01
• Completion: 2002-12-01
• First posted: 2003-01-27
• Last updated: 2013-12-19

Locations

3 sites across 1 country: United Kingdom