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

Alternate Title

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

Basic Trial Information

Phase: Phase III
Type: Supportive care, Treatment
Status: Active
Age: Not specified
Sponsor: Other
Protocol IDs: CRC-BOC-L52, EU-20033, NCT00006231

Objectives

  1. 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.
  2. Determine whether the nodules that develop after radiotherapy are symptomatic in these patients.
  3. 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

Projected Accrual

A total of 44 patients (22 per arm) will be accrued for this study within 2 years.

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.

Disclaimer

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.

Published Results

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(suppl 2): 168, 2000

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit at the University of Glasgow


Noelle O'Rourke, MD, Protocol chair
Ph: 0414-211-1738
Email: norourke@tinyworld.co.uk

Trial Sites and Contacts

Glasgow, Scotland:

Beatson Oncology Centre
Noelle O'Rourke, MD
Ph: 0414-211-1738

Gartnavel General Hospital
Andrew Peacock, MD
Ph: 44-141-211-3000

Stobhill General Hospital
R Jones, MD
Ph: 44-141-201-3000

  

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