Transplant-Related Lung CancerNORThSTARNCT04782752
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
A study testing Radiation: Varying Doses of RT in people with Transplant-Related Lung Cancer, run by Marc de Perrot at 1 site in Canada.
Trial summary
This is a prospective phase I study to determine the safety and feasibility of non-ablative oligofractionated radiation therapy (NORT) before lung transplantation for patients with underlying pulmonary malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant-Related Lung Cancer
- What is being tested?
- Radiation: Varying Doses of RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2021to 30 Dec 2026
- 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
- Patients with end-stage lung disease and suspected stage I primary lung cancer based on CT and PET scan not accessible to curative treatment, including surgery and ablative SBRT.
- Patients with multifocal pulmonary malignancy, including multifocal lung adenocarcinoma, not accessible to curative treatment, including surgery and ablative SBRT.
- Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic disease, not accessible to curative treatment, including surgery and ablative SBRT.
- Meet eligibility criteria for lung transplantation with the exception of the underlying malignancy.
- Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study.
Who cannot join
- Age < 18
- Mediastinal nodes metastasis demonstrated on EBUS-TBNA
- Distant metastasis demonstrated on PET scan or brain imaging.
- Failure to provide informed consent
- Previous thoracic radiation resulting in significant mediastinal or chest wall overlap precluding re-irradiation
- Any other medical condition that, in the opinion of the multidisciplinary team, may interfere with the subject's participation or compliance with the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Marc de Perrot, MD, MSc, 416 340-5549, Marc.dePerrot@uhn.ca
Fatemeh Zaeimi, MSc, 416-340-5686, Fatemeh.Zaeimi@uhn.ca
About this study
This is a prospective phase I study to determine the safety and feasibility of non-ablative oligofractionated radiation therapy (NORT) before lung transplantation for patients with underlying pulmonary malignancy. We hypothesize that heterogeneous dose distributions could generate a vaccination effect against the tumor by creating anti-tumoral immune response in the body and these patients may be immunized against their tumor which could reduce the risk of cancer recurrence after transplantation despite the anti-rejection medications required for the transplantation.
Read the detailed description
This study is designed to deliver short courses of radiation to the pulmonary malignancy followed by resection of the radiated tumor at the time of transplant.
The study is a 3+3 phase 1 study with incremental dose of radiation to determine the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) will be defined as grade 3+ radiation related toxicity. If one DLT is seen, then an additional 3 patients will be treated at the same dose level. If 2 or more DLT are seen at any given dose level, then the previous dose level will be defined as the MTD. A minimum of 3 patients and maximum of 18 patients will be included for the phase 1a. Due to the expected higher radiation risks in patients with end-stage ILD (group 1), these patients will be stratified separately from non-ILD patients (group 2, 3 and 4) during phase 1a. Dose tested are: 3 x 400 cGy, 3 x 600 cGy and 3 x 800 cGy for the ILD cohort and 3 x 800 cGy, 3 x 1000 cGy and 3 x 1200 cGy for the non-ILD cohort.
Once the MTD is determined, patients will proceed to phase 1b using the MTD determined in the phase 1a. ILD and non-ILD patients may have different MTD so two separate phase Ib cohorts will be conducted. A total of 12 patients will be included for each cohort in the phase 1b. The dose distribution will be administered using a standard homogenous dose distribution for tumors ≤2 cm, and an heterogeneous dose distribution for tumors >2 cm.
- Conditions
- Transplant-Related Lung Cancer
- Being tested
- Radiation: Varying Doses of RT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: Varying Doses of RTRadiation
3+3 radiation dose escalation model to see the maximum tolerated dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Radiation | Experimental | Patients will be differentiated into 4 groups:
1. Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer
2. Patients with end-stage lung disease other than ILD (e.g. emphysema/COPD, cystic fibrosis and pulmonary hypertension) and suspected stage I (up to 4 cm) primary lung cancer
3. Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis.
4. Patients with isolated pulmonary metastasis in the absence of other sites of malignancy (primary and metastatic).
For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached. Receives: Radiation: Radiation: Varying Doses of RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose for Radiation
AEs will be graded by CTCAE. Maximum tolerated dose is the dose level do not result in fatal injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+).
Safety will be determined by the absence of grade 3 or greater (G3+) complications related to radiation and the feasibility to list patients for transplantation one week after the end of radiation will be determined.
Measured: Up to four years
Secondary outcomes (2)
Patient Morbidity
NCI common toxicity scale
Measured: Up to four years
Local recurrence
Documented radiographically
Measured: Up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start28 Apr 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related Lung CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 radiation dose escalation
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc de Perrot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc de Perrot, University Health Network, Toronto
- Investigators
- Marc de Perrot, MD, FRCS, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782752
- Sponsor's protocol ID
- 20-5902
- Acronym
- NORThSTAR
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
- ClinicalTrials.gov ID
- NCT04782752
- Acronym / sponsor ID
- NORThSTAR / 20-5902
- Conditions
- Transplant-Related Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marc de PerrotUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective phase I study to determine the safety and feasibility of non-ablative oligofractionated radiation therapy (NORT) before lung transplantation for patients with underlying pulmonary malignancy. We hypothesize that heterogeneous dose distributions could generate a vaccination effect against the tumor by creating anti-tumoral immune response in the body and these patients may be immunized against their tumor which could reduce the risk of cancer recurrence after transplantation despite the anti-rejection medications required for the transplantation.
Detailed description
This study is designed to deliver short courses of radiation to the pulmonary malignancy followed by resection of the radiated tumor at the time of transplant.
The study is a 3+3 phase 1 study with incremental dose of radiation to determine the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) will be defined as grade 3+ radiation related toxicity. If one DLT is seen, then an additional 3 patients will be treated at the same dose level. If 2 or more DLT are seen at any given dose level, then the previous dose level will be defined as the MTD. A minimum of 3 patients and maximum of 18 patients will be included for the phase 1a. Due to the expected higher radiation risks in patients with end-stage ILD (group 1), these patients will be stratified separately from non-ILD patients (group 2, 3 and 4) during phase 1a. Dose tested are: 3 x 400 cGy, 3 x 600 cGy and 3 x 800 cGy for the ILD cohort and 3 x 800 cGy, 3 x 1000 cGy and 3 x 1200 cGy for the non-ILD cohort.
Once the MTD is determined, patients will proceed to phase 1b using the MTD determined in the phase 1a. ILD and non-ILD patients may have different MTD so two separate phase Ib cohorts will be conducted. A total of 12 patients will be included for each cohort in the phase 1b. The dose distribution will be administered using a standard homogenous dose distribution for tumors ≤2 cm, and an heterogeneous dose distribution for tumors >2 cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 radiation dose escalation
| Arm | Type | Receives |
|---|---|---|
| Experimental: Radiation | Experimental | Radiation: Radiation: Varying Doses of RTPatients will be differentiated into 4 groups: 1. Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer 2. Patients with end-stage lung disease other than ILD (e.g. emphysema/COPD, cystic fibrosis and pulmonary hypertension) and suspected stage I (up to 4 cm) primary lung cancer 3. Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis. 4. Patients with isolated pulmonary metastasis in the absence of other sites of malignancy (primary and metastatic). For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Patients with end-stage lung disease and suspected stage I primary lung cancer based on CT and PET scan not accessible to curative treatment, including surgery and ablative SBRT.
- Patients with multifocal pulmonary malignancy, including multifocal lung adenocarcinoma, not accessible to curative treatment, including surgery and ablative SBRT.
- Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic disease, not accessible to curative treatment, including surgery and ablative SBRT.
- Meet eligibility criteria for lung transplantation with the exception of the underlying malignancy.
Key exclusion criteria (6 listed)
- Age < 18
- Mediastinal nodes metastasis demonstrated on EBUS-TBNA
- Distant metastasis demonstrated on PET scan or brain imaging.
- Failure to provide informed consent
- Previous thoracic radiation resulting in significant mediastinal or chest wall overlap precluding re-irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation: Varying Doses of RT3+3 radiation dose escalation model to see the maximum tolerated dose | Radiation | Experimental: Radiation |
Primary outcome
Maximum Tolerated Dose for Radiation
Time frame: Up to four years
AEs will be graded by CTCAE. Maximum tolerated dose is the dose level do not result in fatal injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+). Safety will be determined by the absence of grade 3 or greater (G3+) complications related to radiation and the feasibility to list patients for transplantation one week after the end of radiation will be determined.
2 secondary outcomes
Patient Morbidity
Time frame: Up to four years
Local recurrence
Time frame: Up to four years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc de Perrot, MD, FRCS principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Varying Doses of RT in people with Transplant-Related Lung Cancer, run by Marc de Perrot 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 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?
Contact Marc de Perrot, MD, MSc (416 340-5549, marc.deperrot@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose for Radiation (time frame: Up to four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.