Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
NCT ID: NCT05655078
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2024-03-28
2029-09-30
Brief Summary
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Detailed Description
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Primary endpoint: Progression free survival (PFS) and overall survival (OS), defined as the time from randomisation to the date of progression and death from any cause.
Secondary Endpoints: Safety and Tolerability, Health related Quality of Life (QOL): EuroQoL EQ-5D-3L, Locoregional Control.
Randomisation and stratification: 1:1 randomisation. Patients with be stratified for histology (epithelioid versus non-epithelioid), potential PBT centre (UCLH or The Christie)
, laterality (left or right sided) and time since diagnosis (\<1 year or \> 1 year)
Treatment:
Experimental Arm: Patients in the experimental arm will receive PBT to the hemithorax to a dose of 50Gy in 25 fractions with a boost to 60Gy for the visible tumour (gross tumour volume-GTV). Treatment is given daily Monday-Friday over 5 weeks. Following completion of treatment in the experimental arm patients will have 2 years of follow-up from time of randomisation at the local recruiting/referring centre.
Control Arm:
The patients in the control arm would be under standard of care surveillance i.e. "watch and wait", with no treatment or other intervention. Patients will have 2 years of follow-up from time of randomisation at the local recruiting/referring centre. If the disease progresses, the patient will receive SOC treatment i.e. immunotherapy with nivolumab and ipilimumab, or chemotherapy at the clinician's discretion.
Statistical analysis plan:
The sample size is 148 patients (74 patients per arm). This is to detect a OS hazard ratio of 0.58, equivalent to an improvement in 2-year OS from 30% to 50%, with 85% power and 5% two-sided alpha. Recruitment to complete in 3 years across 20 UK centres with 2 years of additional follow-up and up to 5% dropout. Interim analyses for OS efficacy will be performed when 50, 75 and 110 patients have been randomised at around 1.5, 2.0 and 2.5 years respectively. Using a fixed-sequence approach, a difference for OS will only be tested if the co-primary endpoint of PFS is statistically significant (p\<0.05); N=148 will provide \>85% power to detect a PFS hazard ratio of 0.58 accounting for up to 10% dropout.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care
MPM participants who are on the standard of care watch and wait approach i.e. immediate treatment not suitable. Participants will have follow-up for 2 years (3 monthly in year 1, 4 monthly in year 2).
No interventions assigned to this group
Proton beam therapy
MPM participants to receive 5 weeks of proton beam therapy to the hemithorax. Following completion of treatment participants will have follow-up at the referring centre for 2 years (3 monthly in year 1, 4 monthly in year 2).
Proton beam therapy
5 weeks (Mon-Fri) of proton beam treatment to the hemithorax to a dose of 50Gy in 25 fractions with a boost to 60Gy for the visible tumour (gross tumour volume-GTV).
Interventions
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Proton beam therapy
5 weeks (Mon-Fri) of proton beam treatment to the hemithorax to a dose of 50Gy in 25 fractions with a boost to 60Gy for the visible tumour (gross tumour volume-GTV).
Eligibility Criteria
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Inclusion Criteria
* N0 or N1 and M0 disease
* Written informed consent
* Patient and responsible clinician opt for active surveillance and deferral of systemic anti-cancer therapy until clinical or radiological progression
* WHO Performance Status 0-1
* Disease confined to one hemithorax based on CT assessment
* Adequate pulmonary function:
* ≥ 40% predicted post-FEV1;
* ≥ 40% predicted DLCO/TLCO
* Agreement to travel to either proton beam therapy centres (i.e. UCLH or The Christie) if randomised to arm 2
* Agreement to be followed up at a local HIT-Meso trial site
Exclusion Criteria
* Prior thoracic radiotherapy, chemotherapy, immunotherapy for MPM
* Prior radical surgery for MPM (extrapleural pneumonectomy or extended pleurectomy decortication or pleurectomy decortication)
* Initial systemic therapy or surgery is required and the patient and responsible clinician do not opt for active surveillance
* Involvement of contralateral or supraclavicular lymph nodes
* T4 disease with clear invasion of the myocardium
* N2 and/or M1 disease
* Presence of new effusion that is not amenable to drainage
* WHO Performance Status ≥ 2
* Women who are pregnant or breast feeding
* History of other malignancy; Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of treated non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission, or (e) indolent prostate cancer requiring no or only anti-hormonal therapy.
18 Years
ALL
No
Sponsors
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Asthma + Lung UK
UNKNOWN
Mesothelioma UK
UNKNOWN
University of Sheffield
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Crispin Hiley
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Royal Berkshire Hospital
Reading, England, United Kingdom
Southend University Hospital
Southend, Essex, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
Queen Elizabeth Hospital, King's Lynn
Kings Lynn, Norfolk, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Lilian Cheung
Role: primary
Rafiqul Islam
Role: primary
Hannah Bainbridge
Role: primary
Kamalram Thippu Jayaprakash
Role: primary
Huiqi Yang
Role: primary
Paul Shaw
Role: primary
Thomas Sarkodie
Role: primary
Pandora Rudd
Role: primary
Crispin Hiley
Role: primary
Paul Taylor
Role: primary
Other Identifiers
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MCTA22F\7
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCL/148232
Identifier Type: -
Identifier Source: org_study_id