Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2000 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Glasgow
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006231
First received: September 11, 2000
Last updated: August 19, 2009
Last verified: October 2000
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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 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
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 |
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 | |
| 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:
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.
| ClinicalTrials.gov Identifier: | NCT00006231 History of Changes |
| Other Study ID Numbers: | CDR0000068155, CRC-BOC-L52, EU-20033 |
| Study First Received: | September 11, 2000 |
| Last Updated: | August 19, 2009 |
| 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:
|
Mesothelioma Postoperative Complications Adenoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013