Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	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

Expected Enrollment

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

Outcomes

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.

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.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit at University of Glasgow

Noelle O'Rourke, MD, Protocol chair		Ph: 44-141-211-1738 Email: noelle.orourke@northglasgow.scot.nhs.uk

Registry Information
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
Trial Start Date		1998-02-19
Registered in ClinicalTrials.gov		NCT00006231
Date Submitted to PDQ		2000-06-23
Information Last Verified		2000-10-16

Back to Top