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

Perioperative/Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006231
• Other study ID #: CDR0000068155
• Secondary ID: CRC-BOC-L52EU-20
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2000
• Last updated: December 18, 2013
• Start date: February 1998
• Est. completion date: December 2002

Study information

• Verified date: October 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• quality-of-life assessment

• standard follow-up care

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Gartnavel General Hospitall	Glasgow	Scotland
United Kingdom	Stobhill General Hospital	Glasgow	Scotland
United Kingdom	West of Scotland Cancer Centre	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of metastatic skin nodules			No