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	Phase
localized malignant mesothelioma advanced malignant mesothelioma perioperative/postoperative complications Quality of Life	Procedure: complications of therapy assessment/management  Procedure: quality-of-life assessment  Procedure: radiation therapy  Procedure: supportive care/therapy	Phase III

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

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

United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting
      Gartnavel General Hospital, Glasgow,  Scotland,  G12 0YN,  United Kingdom; Recruiting
      Stobhill General Hospital, Glasgow,  Scotland,  G21 3UW,  United Kingdom; Recruiting

Study chairs or principal investigators

Noelle O'Rourke, MD,  Study Chair,  University of Glasgow   

Study ID Numbers:  CDR0000068155; CRC-BOC-L52; EU-20033; NCT00006231
Record last reviewed:  September 2000
Last Updated:  December 6, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006231
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08