Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
NCT ID: NCT00006231
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
1998-02-28
2002-12-31
Brief Summary
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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
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* 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
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Keywords
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Study Design
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TREATMENT
Interventions
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quality-of-life assessment
standard follow-up care
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Not specified
Life expectancy:
* At least 3 months
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
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
ALL
No
Sponsors
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University of Glasgow
OTHER
Principal Investigators
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Noelle O'Rourke, MD
Role: STUDY_CHAIR
University of Glasgow
Locations
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West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Gartnavel General Hospitall
Glasgow, Scotland, United Kingdom
Stobhill General Hospital
Glasgow, Scotland, United Kingdom
Countries
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References
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O'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.
Other Identifiers
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CRC-BOC-L52
Identifier Type: -
Identifier Source: secondary_id
EU-20033
Identifier Type: -
Identifier Source: secondary_id
CDR0000068155
Identifier Type: -
Identifier Source: org_study_id