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Clinical Trials/NCT00006231
NCT00006231
Completed
Phase 3

A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma

University of Glasgow3 sites in 1 country44 target enrollmentFebruary 1998

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Malignant Mesothelioma
Sponsor
University of Glasgow
Enrollment
44
Locations
3
Primary Endpoint
Incidence of metastatic skin nodules
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1998
End Date
December 2002
Last Updated
12 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of metastatic skin nodules

Study Sites (3)

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