Malignant Pleural MesotheliomaHIT-MesoNCT05655078
Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
A study testing Proton beam therapy in people with Malignant Pleural Mesothelioma, run by University College, London at 25 sites in United Kingdom.
Trial summary
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Proton beam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- 28 Mar 2024to 30 Sep 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age, with biopsy confirmed MPM and histological subtyping (epithelioid or non-epithelioid)
- N0 or N1 and M0 disease
- Written informed consent
- Patient and local/regional MDT opt for active surveillance and deferral of SACT until clinical or radiological progression
- WHO Performance Status 0-1
- Disease confined to one hemithorax based on CT assessment
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- 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
- Patient likely able to complete PBT planning based on local assessment
Who cannot join
- Presence of metastatic or contralateral disease
- Cytological diagnosis and/or undetermined histological subtype
- 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 local/regional MDT do not opt for active surveillance
- Involvement of contralateral or supraclavicular lymph nodes
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- T4 disease with 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
- Current or previous malignant disease which may impact on the patient's life expectancy
- Patient fitted with a pacemaker or implantable cardioverter-defibrillator (ICD)\
- Diagnosis of clinically significant interstitial lung disease (ILD), excluding mild fibrosis or incidental findings
- Chronic non-malignant disease with an estimated three-year survival rate of less than 20%
- Patient with prior thoracic / abdominal radiotherapy for malignancy who was not discussed with sponsor before recruitment
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
United Kingdom25 sites, 24 recruiting
- Recruiting
Furness General Hospital
Barrow in Furness, LA14 4LF
Amy Ford, amy.ford@mbht.nhs.uk, amy.ford@mbht.nhs.uk
Amy Ford
- Recruiting
Betsi Cadwaladr University Health Board -Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ
Angel Garcia, Angel.Garcia@wales.nhs.uk
Angel Garcia
- Recruiting
Southmead Hospital
Bristol, BS105NB
Nick Maskell, nick.maskell@nbt.nhs.uk
Nick Maskell
- Recruiting
Addenbrooke's Hospital
Cambridge, CB20QQ
Huiqi Yang, h.yang@nhs.net
Huiqi Yang
- Recruiting
Velindre Cancer Centre
Cardiff
Paul Shaw, paul.p.shaw@wales.nhs.uk
Paul Shaw
- Recruiting
Broomfield Hospital
Chelmsford, CM1 7ET
Thomas Sarkodie, thomas.sarkodie@nhs.net
Thomas Sarkodie
- Recruiting
East Sussex Healthcare NHS Trust - Eastbourne Hospital
Eastbourne, East Sussex
Edward Chandy, 0127369955 ext. 63461, e.chandy@nhs.net
- Recruiting
Queens Centre, Castle Hill Hospital
Hull, HU165JQ
Dr Louise Karsera, louise.karsera@nhs.net
Dr Louise Karsera
- Recruiting
Queen Elizabeth Hospital, King's Lynn
Kings Lynn, Norfolk, PE30 4ET
Kamalram Thippu Jayaprakash, kamalram.thippujayaprakash@qehkl.nhs.uk
Kamalram Thippu Jayaprakash
- Recruiting
Royal Lancaster Hospital
Lancaster, LA1 4RP
Amy Ford, amy.ford@mbht.nhs.uk, amy.ford@mbht.nhs.uk
Amy Ford
- Recruiting
St James University Hospital
Leeds, LS97TF
Mark Teo, mark.teo@nhs.net
mark.teo@nhs.net
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
Thiagarajan Sridhar, thiagarajan.sridhar@uhl-tr.nhs.uk
Thiagarajan Sridhar
- Recruiting
Clatterbridge Cancer Centre
Liverpool, L78YA
Tony Pope, tony.pope@nhs.net
Pope, tony.pope@nhs.net
- Recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Pandora Rudd, pandora.rudd@nhs.net
Pandora Rudd
- Recruiting
University College London Hospital
London
Crispin Hiley, crispinhiley@nhs.net
Crispin Hiley
- Recruiting
Maidstone Hospital
Maidstone, ME169QQ
Riyaz Shah, riyaz.shah@nhs.net
riyaz.shah@nhs.net
- Active, not recruiting
Christie Hospital
Manchester, M20 4BX
- Recruiting
Wythenshawe Hospital
Manchester, M23 9LT
Paul Taylor, paul.taylor2@mft.nhs.uk
Paul Taylor
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE77DN
Helen Turnbull, helenturnbull@nhs.net
Helen Turnbull
- Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire
Hannah Bainbridge, hannah.bainbridge@porthosp.nhs.uk
Hannah Bainbridge
- Recruiting
Royal Berkshire Hospital
Reading, England, RG15AN
Lilian Cheung, Lilian.Cheung@royalberkshire.nhs.uk
Lilian Cheung
- Recruiting
East Sussex Healthcare NHS Trust - Conquest Hospital
Saint Leonards-on-Sea, East Sussex
Edward Chandy, 0127369955 ext. 63461, e.chandy@nhs.net
- Recruiting
Weston Park Cancer Centre
Sheffield, S102SJ
Tathagata Das, tathagatadas@nhs.net
Tathagata Das
- Recruiting
Southend University Hospital
Southend, Essex, SS0 0RY
Rafiqul Islam, rafiqul.islam@nhs.net
Rafiqul Islam
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
Louise Medley, louise.medley@nhs.net
Louise Medley
About this study
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
Read the detailed description
Study design: Randomised phase III clinical trial for patients with unilateral MPM.
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
- Malignant Pleural Mesothelioma
- Being tested
- Proton beam therapy
- Keywords
- Proton beam therapy
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton beam therapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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). |
| Proton beam therapy | Experimental | 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). Receives: Radiation: Proton beam therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Defined as the time from randomisation to the date of disease progression
Measured: From randomisation up to 2 years of follow up
Overall survival
defined as the time from randomisation to the date of death from any cause.
Measured: From randomisation up to 2 years of follow up
Secondary outcomes (5)
Number of PBT-related adverse events as assessed by CTCAE v5.0
AEs related to proton beam therapy will be collected
Measured: From start of PBT up to 2 years of follow up, for long term effects
The EORTC quality of life questionnaire (QLQ), EORTC QLQ-C30 score, scale of 0-100.
Participant reported quality of life outcomes. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life (QoL scale), and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: From randomisation up to 2 years of follow up
ED-5D-5L score
Participant reported quality of life outcomes. The questionnaire comprises descriptive systems: mobility, self care, usual activities, pain/discomfort, anxiety/depression; scored from, level 1 to 5; level 1 indicating no problem and level 5 indicating unable to/extreme problems. There is also a scale from 0-100 to describe health status, 100 being the best health the patient can imagine, 0 being the worst health they can imagine.
Measured: From randomisation up to 2 years of follow up
Participant reported healthcare resource use from information collected on Client Service Receipt Inventory (CSRI)
A tool used to collect participant reported information on the range of healthcare services and supports study participants may use, to calculate the rate of service usage to evaluate resource use as part of health economic analysis.
Measured: From randomisation up to 2 years of follow up
Measurement of costs in economic evaluations using iMTA Valuation of Informal Care (iVICQ) questionnaire
Scoring (no scale) to evaluate health economics comparing PBT vs SOC surveillance and other SOC treatments for malignant pleural mesothelioma.
Measured: From randomisation up to 2 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start28 Mar 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control arm (standard of care) vs experimental arm (proton beam therapy) in 1:1 randomisation
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Asthma + Lung UK, Mesothelioma UK, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Crispin Hiley, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655078
- Sponsor's protocol ID
- UCL/148232
- Other IDs
- MCTA22F\7
- Acronym
- HIT-Meso
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No