Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
Information source: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Mesothelioma; Metastatic Cancer
Intervention: talc (Other); therapeutic thoracoscopy (Procedure); therapeutic videothoracoscopy (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Papworth Hospital NHS Foundation Trust Official(s) and/or principal investigator(s): Robert Winter, MD, Principal Investigator, Affiliation: Papworth Hospital
Summary
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.
Clinical Details
Official title: Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Survival at 1 year after treatment
Secondary outcome: Control of pleural effusionComplications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days Symptoms and quality of life as assessed by the EuroQol questionnaire Length of hospital stay Exercise tolerance 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
Detailed description:
OBJECTIVES:
Primary
- Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs
talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven
malignant mesothelioma.
Secondary
- Compare the control of pleural effusion in these patients.
- Compare procedure-related complications in these patients.
- Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after
treatment.
- Compare the length of hospital stay for these patients.
- Compare the exercise tolerance of these patients at 3, 6, and 12 months after
treatment.
- Determine the 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.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs
low). Patients are randomized to 1 of 2 treatment arms.
- Arm I (video-assisted thoracoscopic [VAT] cytoreductive pleurectomy): Patients undergo
VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of
biopsy results.
- Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling
intercostal chest drain or via thoracoscopy either at the time of biopsy or after
confirmation of biopsy results.
Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6,
and 12 months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Basildon University Hospital, Basildon, England SS16 5NL, United Kingdom
Papworth Hospital, Cambridge, England CB3 8RE, United Kingdom
Glenfield Hospital, Leicester, England LE3 9QP, United Kingdom
Guy's Hospital, London, England SE1 9RT, United Kingdom
Royal Hallamshire Hospital, Sheffield, England S1O 2JF, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2003
Last updated: June 27, 2013
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