Metastatic Cancer Clinical Trial
— MesoVATSOfficial title:
Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of
the chest cavity may be effective in treating pleural effusion and cause less damage to
normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is
not yet known which therapy is more effective in treating pleural effusion caused by
malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well
it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
Status | Completed |
Enrollment | 196 |
Est. completion date | May 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Confirmed or suspected mesothelioma - Any subtype allowed - Pleural effusion must be present PATIENT CHARACTERISTICS: - Clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy - Prior malignancy allowed provided it no longer requires treatment AND patient has a confirmed diagnosis of mesothelioma PRIOR CONCURRENT THERAPY: - No prior attempted pleurodesis by any approach |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Basildon University Hospital | Basildon | England |
United Kingdom | Papworth Hospital | Cambridge | England |
United Kingdom | Glenfield Hospital | Leicester | England |
United Kingdom | Guy's Hospital | London | England |
United Kingdom | Royal Hallamshire Hospital | Sheffield | England |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival at 1 year after treatment | 1 year | No | |
Secondary | Control of pleural effusion | 1 year | No | |
Secondary | Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days | 1 year | No | |
Secondary | Symptoms and quality of life as assessed by the EuroQol questionnaire | 0, 1, 3, 6 12 months | No | |
Secondary | Length of hospital stay | 1 year | No | |
Secondary | Exercise tolerance | 0, 1, 3, 6 12 months | No | |
Secondary | Cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months | 0, 1, 3, 6 12 months | No |
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