Lung CancerSTRICTSTARLUNGNCT05354596
A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).
A study testing STRICT LUNG and STAR LUNG in people with Lung Cancer and Metastases to Lung, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial summary
An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastases to Lung, Radiotherapy Side Effect
- What is being tested?
- STRICT LUNG and STAR LUNG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Nov 2022to 1 May 2033
- 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
- Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.
- ECOG performance status ≤ 2.
- Age > 18 years old. • Life expectancy > 6 months.
- Maximum one central tumor with the diameter ≤ 5 cm or > 1 adjacent located tumors with a summarized diameter (measured from the outer margin from one tumor to the outer margin of the other) of maximum 5 cm on a diagnostic CT-scan.
- Medically inoperable or refused surgery.
- The central tumors must be localized within or touching the 2.5 cm-zone of the PBT, or within 0.5 cm from the spinal cord, esophagus or heart. Evaluation is primarily performed on the diagnostic CT scan
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- All metastatic sites are treated or planned for ablative therapy (including surgery). For oligo-progressive disease (OPD), only the sites in progression are required to fulfil this criterion
- Adequate lung function to tolerate treatment, at the discretion of the treating physician. • Ability to understand and willingness to sign a written informed consent document. • Patient must be accessible to treatment and follow-up procedures
- Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use effective contraception for the duration of study treatment and one month thereafter.
- Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of the trachea, main bronchi or intermediate bronchus. Evaluation is primarily performed on the diagnostic CT scan
- Patients with other non-central tumors synchronous with the central lesion may be included and treated with SBRT in respect to local practice.
- A baseline PET/CT scan within 2 months of inclusion.
- An ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide.
Who cannot join
- Tumor with intra-bronchial or intra-tracheal growth, as assessed on a diagnostic CT/MR-scan or endoscopic procedure
- If the patient has received previous radiotherapy, the combined dose at the radiation site must be evaluated by the treating physician and preferably not exceed the dose constraints
- Patient cannot tolerate the physical set up required for SBRT. • Uncontrolled intercurrent illness
- Pregnancy
- Patient participating in another interventional study
- For patients in STAR-LUNG, lack of MR compatibility due to pacemaker, inserted steel or similar.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9100
Rasmus Kjeldsen, MD
Hella Sand, MSc, hmbs@rn.dk
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Azza A Khalil, MD, PhD, azza.khalil@auh.rm.dk
Marianne M Knap, MD, PhD, mari.knap@auh.rm.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Mette pøhl, MD, PhD, 41667681, mette.poehl@regionh.dk
Cécile Peucelle, MSc, PhD, cecile.anne.peucelle@regionh.dk
- Recruiting
Herlev University Hospital
Herlev, 2730
Gitte F Persson, MD, PhD, Gitte.Persson@regionh.dk
Wiviann Ottosson, MSc
- Recruiting
Odense University Hospital
Odense, 5000
Tine Schytte, Prof. MD. PhD, Tine.Schytte@rsyd.dk
Tine Bj Nielsen, MSc, PhD
- Recruiting
Department of Oncology, Lillebaelt Hospital
Vejle, 7100
Charlotte Kristiansen, MD, Charlotte.Kristiansen@rsyd.dk
Rune S Thing, MSc
About this study
Official title: Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung. STRICT-LUNG & STAR-LUNG STUDY
An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Read the detailed description
The STRICT-LUNG study will evaluate the feasibility and safety of daily image-guided SBRT in centrally located lung tumors (primary, oligo-metastatic or oligo-progressive). The STAR-LUNG study will evaluate the feasibility and safety of daily adaptive MR-linac based SBRT in ultra-centrally located lung tumors (primary, oligo-metastatic or oligo-progressive).
The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located <0.5 cm from the spinal cord, heart and aorta.
Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment).
The main purposes are to evaluate the feasibility, safety and efficacy of stereotactic radiation to centrally and ultra-centrally located tumors, including treatment related adverse events, quality of life (QoL) assessments, local tumor control rate, disease free survival, and overall survival and facilitate future stratification of this patient group for definitive treatment.
Treatment related adverse events (TRAE) will be registered at baseline, end of treatment, 4-6 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after treatment, and hereafter every year until 10th year of follow-up.
Enrolment in both trial categories may continue until the required numbers in both groups have been reached.
- Conditions
- Lung Cancer, Metastases to Lung, Radiotherapy Side Effect
- Being tested
- STRICT LUNG, STAR LUNG
- Keywords
- Stereotactic body radiotherapy (SBRT)
- Medical subject headings
- Lung Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRICT LUNGProcedure or surgery
Also called Stereotactic radiotherapy for centrally located lung tumors
Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.
STAR LUNGProcedure or surgery
Also called Stereotactic radiotherapy for ultra-centrally located lung tumors
Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
| Study group | Role | What they receive |
|---|---|---|
| STRICT LUNG | Experimental | Central Tumors in the Lung The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located <0.5 cm from the spinal cord, heart and aorta. Receives: Procedure: STRICT LUNG |
| STAR LUNG | Experimental | Ultra-Centrally Tumors in the Lung Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment). Receives: Procedure: STAR LUNG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Measured: Assessed at 6 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Measured: Assessed at 12 months
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Measured: Assessed at 2 years
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Measured: Assessed at 5 years
Secondary outcomes (4)
Local progression free survival (LPFS)
Local progression-free survival (LPFS) is defined from the start of radiotherapy treatment until death or date of local recurrence. Events are death and local recurrence.
Measured: Up to 10 years
Overall survival (OS)
Overall survival (OS) is defined as the time from start of radiotherapy treatment until death by any cause.
Measured: Up to 10 years
Disease free survival (DFS)
Disease free survival (DFS) is defined from start of radiotherapy treatment until date of first locoregional or metastatic recurrence or death from any cause. Events are recurrence and death.
Measured: Up to 10 years
Time-to-treatment failure (TTF)
Time-to-treatment failure (TTF) is defined as time from start of radiotherapy treatment until the date of relapse; the patient has withdrawn patient consent or premature termination of SBRT due to toxicity. Events are death due to primary cancer, death due to protocol treatment and date of local, regional or metastatic recurrence.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Nov 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Radiation: SBRT of central located and ultra-centrally located tumors in the lung. Primary lung tumors and lung metastasis from solid tumors.
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Vejle Hospital, University of Copenhagen, Aalborg University Hospital
- Responsible party
- Principal investigator, Mette Pøhl, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354596
- Sponsor's protocol ID
- H-21041667
- Acronym
- STRICTSTARLUNG
- Status last verified
- Mar 2023
- First submitted
- 18 Apr 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoffmann L, Persson GF, Nygard L, Nielsen TB, Borrisova S, Gaard-Petersen F, Josipovic M, Khalil AA, Kjeldsen R, Knap MM, Kristiansen C, Moller DS, Ottosson W, Sand H, Thing R, Pohl M, Schytte T. Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours. Radiother Oncol. 2022 Jun;171:53-61. doi: 10.1016/j.radonc.2022.04.005. Epub 2022 Apr 11.
PubMed 35421513
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung. STRICT-LUNG & STAR-LUNG STUDY
- ClinicalTrials.gov ID
- NCT05354596
- Acronym / sponsor ID
- STRICTSTARLUNG / H-21041667
- Conditions
- Lung Cancer, Metastases to Lung, Radiotherapy Side Effect
- Keywords
- Stereotactic body radiotherapy (SBRT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Vejle Hospital, University of Copenhagen, Aalborg University Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 29 Apr 2022 (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.
An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.
Detailed description
The STRICT-LUNG study will evaluate the feasibility and safety of daily image-guided SBRT in centrally located lung tumors (primary, oligo-metastatic or oligo-progressive). The STAR-LUNG study will evaluate the feasibility and safety of daily adaptive MR-linac based SBRT in ultra-centrally located lung tumors (primary, oligo-metastatic or oligo-progressive).
The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located <0.5 cm from the spinal cord, heart and aorta.
Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment).
The main purposes are to evaluate the feasibility, safety and efficacy of stereotactic radiation to centrally and ultra-centrally located tumors, including treatment related adverse events, quality of life (QoL) assessments, local tumor control rate, disease free survival, and overall survival and facilitate future stratification of this patient group for definitive treatment.
Treatment related adverse events (TRAE) will be registered at baseline, end of treatment, 4-6 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after treatment, and hereafter every year until 10th year of follow-up.
Enrolment in both trial categories may continue until the required numbers in both groups have been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Radiation: SBRT of central located and ultra-centrally located tumors in the lung. Primary lung tumors and lung metastasis from solid tumors.
| Arm | Type | Receives |
|---|---|---|
| STRICT LUNG | Experimental | Procedure: STRICT LUNGCentral Tumors in the Lung The tumor is considered central when the tumor is located within 0.5 -2.5 cm in all directions of the PBT or the esophagus. The PBT includes trachea, main bronchi and intermediate bronchus and 5 lobar bronchi. In addition, the tumor is also considered central, if it is located <0.5 cm from the spinal cord, heart and aorta. |
| STAR LUNG | Experimental | Procedure: STAR LUNGUltra-Centrally Tumors in the Lung Ultra-centrally located tumors are tumors located within the 0.0 to 0.5 cm zone of trachea, main bronchi or intermediate bronchus. The patient will be excluded if the tumor invades the trachea, bronchi, esophagus, or pericardium/heart (radiological or by bronchoscopy assessment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histology or cytology proven non-hematological cancer or known cancer with local progressive recurrence.
- ECOG performance status ≤ 2.
- Age > 18 years old. • Life expectancy > 6 months.
- Maximum one central tumor with the diameter ≤ 5 cm or > 1 adjacent located tumors with a summarized diameter (measured from the outer margin from one tumor to the outer margin of the other) of maximum 5 cm on a diagnostic CT-scan.
- Medically inoperable or refused surgery.
Key exclusion criteria (6 listed)
- Tumor with intra-bronchial or intra-tracheal growth, as assessed on a diagnostic CT/MR-scan or endoscopic procedure
- If the patient has received previous radiotherapy, the combined dose at the radiation site must be evaluated by the treating physician and preferably not exceed the dose constraints
- Patient cannot tolerate the physical set up required for SBRT. • Uncontrolled intercurrent illness
- Pregnancy
- Patient participating in another interventional study
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 |
|---|---|---|
| STRICT LUNGAlso: Stereotactic radiotherapy for centrally located lung tumorsStereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. | Procedure or surgery | STRICT LUNG |
| STAR LUNGAlso: Stereotactic radiotherapy for ultra-centrally located lung tumorsStereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation. | Procedure or surgery | STAR LUNG |
Primary outcome
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time frame: Assessed at 6 months
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time frame: Assessed at 12 months
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time frame: Assessed at 2 years
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE)
Time frame: Assessed at 5 years
Registration of toxicity will be assessed according to a prespecified selection of organ related adverse events defined by CTCAE version 5.0.
4 secondary outcomes
Local progression free survival (LPFS)
Time frame: Up to 10 years
Overall survival (OS)
Time frame: Up to 10 years
Disease free survival (DFS)
Time frame: Up to 10 years
Time-to-treatment failure (TTF)
Time frame: Up to 10 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 3 Mar 2023.
- Background: PubMed 35421513Hoffmann L, Persson GF, Nygard L, Nielsen TB, Borrisova S, Gaard-Petersen F, Josipovic M, Khalil AA, Kjeldsen R, Knap MM, Kristiansen C, Moller DS, Ottosson W, Sand H, Thing R, Pohl M, Schytte T. Thorough design and pre-trial quality assurance (QA) decrease dosimetric impact of delineation and dose planning variability in the STRICTLUNG and STARLUNG trials for stereotactic body radiotherapy (SBRT) of central and ultra-central lung tumours. Radiother Oncol. 2022 Jun;171:53-61. doi: 10.1016/j.radonc.2022.04.005. Epub 2022 Apr 11.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRICT LUNG and STAR LUNG in people with Lung Cancer and Metastases to Lung, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
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 13 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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 Mette Pøhl, MD, PhD (+4535451824, mette.poehl@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity: Cumulative CTCAE grade ≥ 4 SABR related toxicity (TRAE) (time frame: Assessed at 6 months). The study lists 4 primary outcomes in all. 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 NCT05354596, which also lists 1 linked publication.
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 3 Mar 2023.