Perioperative/Postoperative Complications Clinical Trial
Official title:
A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma
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.
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.
;
Primary Purpose: Treatment
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