Malignant MesotheliomaPhase 3NCT00006231
Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
A Phase 3 study testing quality-of-life assessment, standard follow-up care and radiation therapy in people with Malignant Mesothelioma and Perioperative/Postoperative Complications, run by University of Glasgow at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Mesothelioma, Perioperative/Postoperative Complications
- What is being tested?
- quality-of-life assessment, standard follow-up care and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 1998to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Gartnavel General Hospitall
Glasgow, Scotland, G12 0YN
Stobhill General Hospital
Glasgow, Scotland, G21 3UW
About this study
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
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.
Read the 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.
- Being tested
- quality-of-life assessment, standard follow-up care, radiation therapy
- Keywords
- localized malignant mesothelioma, advanced malignant mesothelioma, perioperative/postoperative complications
- Medical subject headings
- Mesothelioma, Malignant, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
standard follow-up careProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of metastatic skin nodules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 1998
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Noelle O'Rourke, MD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006231
- Sponsor's protocol ID
- CDR0000068155
- Other IDs
- CRC-BOC-L52, EU-20033
- Status last verified
- Oct 2000
- First submitted
- 11 Sep 2000
- Last updated
- 19 Dec 2013
- Results posted
- No
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 at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00006231
- Acronym / sponsor ID
- CDR0000068155
- Keywords
- localized malignant mesothelioma, advanced malignant mesothelioma, perioperative/postoperative complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Feb 1998
- Study completion
- Dec 2002 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Incidence of metastatic skin nodules
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Results publicationO'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelle O'Rourke, MD study chair
University of Glasgow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quality-of-life assessment, standard follow-up care and radiation therapy in people with Malignant Mesothelioma and Perioperative/Postoperative Complications, run by University of Glasgow at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of metastatic skin nodules. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.