AzTrials
AzTrials

Mesothelioma; LungSMARTERNCT04028570

A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection

A study testing Varying Doses of Background and Boost RT in people with Mesothelioma; Lung, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma; Lung
What is being tested?
Varying Doses of Background and Boost RT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
5 Sep 2019to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Good pulmonary function precluding radiation therapy (FEV1>1 L or >40% predicted or DLCO >45% predicted)
  • Any patient with a new histological diagnosis of malignant pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis.
  • Stage T1-3 N0-1 M0 according to the 8th edition of the tumor, node, and metastases (TNM) staging system based on conventional investigations and tests (Appendix 1). Note that the updated TNM staging system now categorizes ipsilateral mediastinal nodes as N1 disease.
  • Suitable for combined modality therapy
  • Informed consent.

Who cannot join

  • Age < 18 years.
  • Contralateral mediastinal nodal disease (N2)
  • Distant metastatic disease (M1).
  • Poor performance status ECOG 3-4.
  • Poor pulmonary function precluding radiation therapy (FEV1<1 L or <40% predicted or diffusion lung capacity for carbon monoxide (DLCO) <45% predicted)
  • Failure to provide informed consent.
Show all 11Show fewer
  • Previous thoracic irradiation.
  • Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
  • Previous chemotherapy for this or concurrent malignancy.
  • Previous or concomitant malignancies except for patients with non-melanoma skin cancer, contralateral non-invasive breast cancer, prostate cancer treated with curative intent or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 3 years previously and without evidence of recurrence will be eligible.
  • Women who are currently pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital, University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. We hypothesize the immunologic abscopal effect is an important component in controlling disease, and may be stimulated with highly hypofractionated doses. Doses will increase with every three patients who will be enrolled in the study until the background radiation reaches 1800 cGy or the maximum tolerated dose, whichever is lower.

Read the detailed description

This study aims to find the maximum tolerated dose level for mesothelioma patients receiving background radiation + boost radiation, and surgery. 3 patients will start with a background radiation therapy (RT) dose of 0 cGy, and boost RT of at least 2100 cGy. If the radiation is manageable (radiation related AEs grade < 4), the next set of 3 patients will be enrolled, and the background radiation dose will be increased by 600 cGy. This will continue until the background radiation dose reaches 1800 cGy. If 1 patient exhibits dose limiting toxicities (AEs grade 4 \& 5), the dose level will repeat with the next 3 patients. If 2 or more patients exhibit DLTs, the previous dose level will be determined as the maximum tolerated dose level. Surgery will be scheduled to occur approximately 1-2 weeks after completing radiation therapy, and will subsequently be followed up as per study schedule.

Being tested
Varying Doses of Background and Boost RT
Keywords
Radiation, Boost Radiation Therapy, Background Radiation Therapy, Surgery, Extensive Pleural Resection
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Varying Doses of Background and Boost RTRadiation

    3+3 radiation dose escalation model to see the maximum tolerated dose for background and boost radiation therapy.

Study groups in NCT04028570
Study groupRoleWhat they receive
RadiationExperimentalThis study involves a 3+3 design. The starting cohort (n=3) will receive a neoadjuvant Background dose to the affected hemithorax (starting at 0 cGy) as well as concomitant Boost dose (of at least 2100 cGy) to a part of the gross tumour volume (GTV). The radiation will be delivered over 3 alternate days over 5-7 calendar days followed by macroscopically complete extensive pleural resection (either extra-pleural pneumonectomy or extended pleurectomy decortication, at the surgeon's discretion) after 7 to 14 days. If no dose limiting toxicities (DLTs) seen, then the Background RT dose will be increased by 600 cGy (up to 1800 cGy) and the cohort (n=3) for the next dose level will be accrued. If only 1 DLT seen, then an additional 3 patients will be treated on this dose level. If 2 or more DLTs seen at any given dose level, then the previous dose level will be defined as the maximum tolerated dose (MTD). Patients will be stratified by type of resection.
Receives: Radiation: Varying Doses of Background and Boost RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose for Background Radiation

    AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+).

    Measured: Up to five years

Secondary outcomes (11)

  1. Patient Morbidity

    NCI common toxicity scale

    Measured: Up to five years

  2. Local recurrence

    Documented radiographically

    Measured: Up to five years

  3. Patients' quality of life

    Short Form Health Survey-36 (SF-36) Form

    Measured: Up to five years

  4. Evaluating patients' pain

    Assess by using the Short Form (BPI-SF)

    Measured: Up to five years

  5. Evaluating patients' pain

    Assess by using The Hospital Anxiety and Depression Scale (HADS)

    Measured: Up to five years

  6. Evaluating patients' pain

    Assess by using the EuroQol EQ-5D-5L Questionnaire

    Measured: Up to five years

  7. Evaluating patients' pain

    Assess by using the Sensitivity to Pain Traumatization Scale (SPTS)

    Measured: Up to five years

  8. Evaluating patients' pain

    Assess by using the ID Pain form

    Measured: Up to five years

  9. Evaluating patients' pain

    Assess by using the Pain Catastrophizing Scale (PCS)

    Measured: Up to five years

  10. Evaluating patients' pain

    Assess by using the Post-traumatic Stress Disorder Checklist-Civilian version (PCL-C)

    Measured: Up to five years

  11. Evaluating patients' pain

    Assess by using a variety of standard instruments including the Injustice Experience Questionnaire (IEQ).

    Measured: Up to five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2019
  2. Study start5 Sep 2019
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Model description
3+3 radiation dose escalation
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04028570
Sponsor's protocol ID
18-5987
Acronym
SMARTER
Status last verified
Mar 2026
First submitted
3 Apr 2019
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Varying Doses of Background and Boost RT in people with Mesothelioma; Lung, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Maximum Tolerated Dose for Background Radiation (time frame: Up to five years). 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 NCT04028570.

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 5 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in