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

Sponsor:	University of Glasgow
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006231

Purpose

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	Intervention	Phase
Malignant Mesothelioma Perioperative/Postoperative Complications	Procedure: quality-of-life assessment Procedure: standard follow-up care Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Estimated Enrollment:	44
Study Start Date:	February 1998

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006231

Locations

United Kingdom, Scotland
Gartnavel General Hospitall
Glasgow, Scotland, United Kingdom, G12 0YN
Stobhill General Hospital
Glasgow, Scotland, United Kingdom, G21 3UW
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT

Sponsors and Collaborators

University of Glasgow

Investigators

Study Chair:

Noelle O'Rourke, MD

University of Glasgow

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000068155, CRC-BOC-L52, EU-20033
Study First Received:	September 11, 2000
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00006231 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized malignant mesothelioma
advanced malignant mesothelioma
perioperative/postoperative complications

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Postoperative Complications

Neoplasms, Mesothelial
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009