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

Sponsor

University of Glasgow (Other)

Overall Status

Completed

CT.gov ID

NCT00006231

Collaborator

(none)

Enrollment

Locations

Duration (Months)

14.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Mesothelioma Perioperative/Postoperative Complications	Procedure: quality-of-life assessment Procedure: standard follow-up care Radiation: radiation therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 1998

Actual Study Completion Date :

Dec 1, 2002

Outcome Measures

Primary Outcome Measures

Incidence of metastatic skin nodules []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G11 6NT
2	Gartnavel General Hospitall	Glasgow	Scotland	United Kingdom	G12 0YN
3	Stobhill General Hospital	Glasgow	Scotland	United Kingdom	G21 3UW