Non Small Cell Lung CancerSTRILLNCT04455438
SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions
A study testing SBRT dose escalation in people with Non Small Cell Lung Cancer and Lung Metastases, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Metastases
- What is being tested?
- SBRT dose escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose RT;
- Peripheral lesion (> 2 cm from trachea-bronchial tree);
- Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area;
- Patients had previously received curative intent RT of more than 50 Gy for conventionally fractionated RT or a biologically equivalent dose of more than 75 Gy for SBRT;
- No active distant metastasis or controlled distant metastasis at the time of re-irradiation
Who cannot join
- Central or ultra-central lesion(s);
- Incapability of understanding and signing informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milano, 20089
Davide Franceschini, MD, +39 0282247428, davide.franceschini@humanitas.it
Mauro Loi, MD, +39 0282247461, mauro.loi@humanitas.it
About this study
Official title: Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Reirradiation of Inoperable Lung Lesions
Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.
Read the detailed description
Radical dose radiotherapy (RT) is frequently used in thoracic malignancies, both for early stage primary non-small cell lung cancer (NSCLC) and for secondary lesions from other primary tumors, particularly in the setting of oligometastatic patients. Although development of distant metastases is the predominant pattern of failure after treatment with radical RT, isolated local recurrences, defined as a tumor recurrence overlapping the 50% isodose field, are still observed and are becoming more and more frequent along with the prolongation of life expectancy in cancer patients. Salvage options for isolated post-radiation local failures are limited, with surgery or retreatment with radiotherapy as potential modalities.
While salvage surgical resection after previous thoracic irradiation has shown encouraging results, most patients experiencing post-radiation local relapse are not surgical candidates. Therefore, reirradiation may be the only viable salvage option for many patients. Retreatment with CFRT has been reported for locoregional failures, with generally-poor outcomes. Although, salvage SBRT after initial CFRT has been described in select small series of heterogeneous patient groups ranging from early stage to locally-advanced and metastatic, few data exist to guide us on the role of reirradiation with SBRT for isolated recurrences after initial SBRT for early-stage NSCLC. Due to the heterogeneity and the low numerosity of these experiences, important questions regarding the safety and efficacy in this setting are still largely unanswered. Particularly, the possibility of delivering a second course of ablative dose RT (BED ≥ 100 Gy) is almost unexplored.
Based on this background, we designed a prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.
- Conditions
- Non Small Cell Lung Cancer, Lung Metastases
- Being tested
- SBRT dose escalation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT dose escalationRadiation
Re-Stereotactic Body Radiation Therapy (SBRT) with increasing dose levels, from 30 Gy in 5 fractions to 50 Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| SBRT Level 1 | Experimental | The starting dose level will be SBRT 30 Gy in 5 fractions (level 1 or L1). Receives: Radiation: SBRT dose escalation |
| SBRT Level 2 | Experimental | If the starting dose is tolerated in the first 5 patients, the next dose will be SBRT 40 Gy in 5 fractions (level 2 or L2) Receives: Radiation: SBRT dose escalation |
| SBRT Level 3 | Experimental | If the second dose is tolerated in the next 5 patients, the next dose will be SBRT 50 Gy in 5 fractions (level 3 or L3) Receives: Radiation: SBRT dose escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
maximal tolerated dose (MTD) of SBRT for thoracic re-irradiation
Measured: 5 years
Secondary outcomes (4)
Other toxicities
To evaluate acute and late toxicities other than dose limiting toxicity
Measured: 5 years
Overall survival
To evaluate overall survival of patients undergoing thoracic re-irradiation.
Measured: 5 years
Local control
To evaluate local control of patients undergoing thoracic re-irradiation.
Measured: 5 years
PFS
To evaluate progression free survival of patients undergoing thoracic re-irradiation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start28 May 2020
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Sequential
- Model description
- The study is designed to determine the Maximum Tolerated Dose (MTD) that could be safely delivered in the lung reirradiation setting. The MTD was defined as the highest dose level in which a proportion of 1 out of 5 or fewer patients experienced DLT. Due to the late onset nature of DLT, in order to allow for continuous accrual without sacrificing patient safety or the accuracy of identifying the MTD, the Time-To-Event Bayesian Optimal Interval (TITE-BOIN) design will be used.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455438
- Sponsor's protocol ID
- 2525
- Acronym
- STRILL
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2020
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Reirradiation of Inoperable Lung Lesions
- ClinicalTrials.gov ID
- NCT04455438
- Acronym / sponsor ID
- STRILL / 2525
- Conditions
- Non Small Cell Lung Cancer, Lung Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Jul 2020 (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.
Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.
Detailed description
Radical dose radiotherapy (RT) is frequently used in thoracic malignancies, both for early stage primary non-small cell lung cancer (NSCLC) and for secondary lesions from other primary tumors, particularly in the setting of oligometastatic patients. Although development of distant metastases is the predominant pattern of failure after treatment with radical RT, isolated local recurrences, defined as a tumor recurrence overlapping the 50% isodose field, are still observed and are becoming more and more frequent along with the prolongation of life expectancy in cancer patients. Salvage options for isolated post-radiation local failures are limited, with surgery or retreatment with radiotherapy as potential modalities.
While salvage surgical resection after previous thoracic irradiation has shown encouraging results, most patients experiencing post-radiation local relapse are not surgical candidates. Therefore, reirradiation may be the only viable salvage option for many patients. Retreatment with CFRT has been reported for locoregional failures, with generally-poor outcomes. Although, salvage SBRT after initial CFRT has been described in select small series of heterogeneous patient groups ranging from early stage to locally-advanced and metastatic, few data exist to guide us on the role of reirradiation with SBRT for isolated recurrences after initial SBRT for early-stage NSCLC. Due to the heterogeneity and the low numerosity of these experiences, important questions regarding the safety and efficacy in this setting are still largely unanswered. Particularly, the possibility of delivering a second course of ablative dose RT (BED ≥ 100 Gy) is almost unexplored.
Based on this background, we designed a prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is designed to determine the Maximum Tolerated Dose (MTD) that could be safely delivered in the lung reirradiation setting. The MTD was defined as the highest dose level in which a proportion of 1 out of 5 or fewer patients experienced DLT. Due to the late onset nature of DLT, in order to allow for continuous accrual without sacrificing patient safety or the accuracy of identifying the MTD, the Time-To-Event Bayesian Optimal Interval (TITE-BOIN) design will be used.
| Arm | Type | Receives |
|---|---|---|
| SBRT Level 1 | Experimental | Radiation: SBRT dose escalationThe starting dose level will be SBRT 30 Gy in 5 fractions (level 1 or L1). |
| SBRT Level 2 | Experimental | Radiation: SBRT dose escalationIf the starting dose is tolerated in the first 5 patients, the next dose will be SBRT 40 Gy in 5 fractions (level 2 or L2) |
| SBRT Level 3 | Experimental | Radiation: SBRT dose escalationIf the second dose is tolerated in the next 5 patients, the next dose will be SBRT 50 Gy in 5 fractions (level 3 or L3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose RT;
- Peripheral lesion (> 2 cm from trachea-bronchial tree);
- Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area;
- Patients had previously received curative intent RT of more than 50 Gy for conventionally fractionated RT or a biologically equivalent dose of more than 75 Gy for SBRT;
- No active distant metastasis or controlled distant metastasis at the time of re-irradiation
Key exclusion criteria (2 listed)
- Central or ultra-central lesion(s);
- Incapability of understanding and signing informed consent.
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 |
|---|---|---|
| SBRT dose escalationRe-Stereotactic Body Radiation Therapy (SBRT) with increasing dose levels, from 30 Gy in 5 fractions to 50 Gy in 5 fractions. | Radiation | SBRT Level 1, SBRT Level 2, SBRT Level 3 |
Primary outcome
MTD
Time frame: 5 years
maximal tolerated dose (MTD) of SBRT for thoracic re-irradiation
4 secondary outcomes
Other toxicities
Time frame: 5 years
Overall survival
Time frame: 5 years
Local control
Time frame: 5 years
PFS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT dose escalation in people with Non Small Cell Lung Cancer and Lung Metastases, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Franceschini, MD (0039 028224 7428, davide.franceschini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 5 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 15 Sep 2022.