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Mesothelioma Clinical Trials

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

This study is currently recruiting patients.

Sponsored by

Cancer Research UK
 
For more information:National Cancer Institute (NCI)

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.

Condition Treatment or Intervention
localized malignant mesothelioma
advanced malignant mesothelioma
perioperative/postoperative complications
Quality of Life
Procedure: complications of therapy management
Procedure: quality-of-life assessment
Procedure: radiation therapy
Procedure: supportive care/therapy

This is a Phase III test

  • In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Radiotherapy in the Prevention of Metastatic Skin Nodules Following Invasive Diagnostic Procedures in Patients With Malignant Mesothelioma

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks 


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