Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information
Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | Not specified | Other | CRC-BOC-L52 EU-20033, NCT00006231 |
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.
Entry Criteria
Disease Characteristics:
- Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks
Prior/Concurrent Therapy:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior systemic chemotherapy for malignant mesothelioma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior local radiotherapy for malignant mesothelioma
Surgery:
- See Disease Characteristics
- No other invasive procedures to the same chest site during and for 1 year after study
Patient Characteristics:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Expected Enrollment
44A total of 44 patients (22 per arm) will be accrued for this study within 2 years.
Outcomes
Primary Outcome(s)Incidence of metastatic skin nodules
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.
Published ResultsO'Rourke N, Paul J, Hill J: Radiotherapy to mesothelioma drain sites may not be worthwhile: interim report of a randomized study. Lung Cancer 29(1 Suppl 1): A-568, 168, 2000.
Trial Lead Organizations
Cancer Research UK Clinical Trials Unit at University of Glasgow
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| Noelle O'Rourke, MD, Protocol chair | |
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| Registry Information | ||
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| 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 | |
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| Trial Start Date | 1998-02-19 | |
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| Registered in ClinicalTrials.gov | NCT00006231 | |
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| Date Submitted to PDQ | 2000-06-23 | |
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| Information Last Verified | 2000-10-16 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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