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

Tracking Information

First Received Date ^ICMJE

September 11, 2000

Last Updated Date

August 19, 2009

Start Date ^ICMJE

February 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of metastatic skin nodules [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Incidence of metastatic skin nodules

Change History

Complete list of historical versions of study NCT00006231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Malignant Mesothelioma
Perioperative/Postoperative Complications

Intervention ^ICMJE

Procedure: quality-of-life assessment
Procedure: standard follow-up care
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00006231

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068155, CRC-BOC-L52, EU-20033

Study Sponsor ^ICMJE

University of Glasgow

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Noelle O'Rourke, MD

University of Glasgow

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP