Lung CancerPhase 1NCT03321747
Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
A Phase 1 study testing Stereotactic Ablative Body Radiation (SABR) in people with Lung Cancer, run by Indiana University at 3 sites in United States.
Trial summary
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Stereotactic Ablative Body Radiation (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Oct 2017to 9 Jul 2020
- Phase
- Phase 1
- 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
- Age ≥ 18 at time of consent.
- Ability to provide written informed consent and HIPAA authorization.
- Pathological diagnosis of squamous cell carcinoma of the lung.
- Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).
- Tumors < 7cm
- Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors)
Show all 9Show fewer
- N0 M0 disease
- Plan to undergo four or five fraction SABR
- Baseline PFTs available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial)
Who cannot join
- Previous radiation therapy to the lung per investigator discretion.
- Inability to comply with treatment per investigator discretion.
- Inability to follow standard of care follow up recommendations per investigator discretion.
- KPS<40
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.
Read the detailed description
- Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung. During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung.
- Phase II Secondary Objectives
- Determine overall survival, progression free survival and patterns of failure after SABR.
- Determine tolerability of dose escalated SABR.
- Conditions
- Lung Cancer
- Being tested
- Stereotactic Ablative Body Radiation (SABR)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Body Radiation (SABR)Radiation
Treatments shall not be delivered more frequently than every other day.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/Dose Level 1 | Experimental | 11 Gy will be given in 5 fractions for a total dose of 55 Gy Receives: Radiation: Stereotactic Ablative Body Radiation (SABR) |
| Phase 1/Dose Level 2 | Experimental | 12 Gy will be given in 5 fractions for a total dose of 60 Gy Receives: Radiation: Stereotactic Ablative Body Radiation (SABR) |
| Phase 1/Dose Level 3 | Experimental | 13 Gy will be given in 5 fractions for a total dose of 65 Gy Receives: Radiation: Stereotactic Ablative Body Radiation (SABR) |
| Phase 1/Dose Level 4 | Experimental | 14 Gy will be given in 5 fractions for a total dose of 70 Gy Receives: Radiation: Stereotactic Ablative Body Radiation (SABR) |
| Phase 2 | Experimental | The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy. Receives: Radiation: Stereotactic Ablative Body Radiation (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.
Measured: 30 days
Secondary outcomes (2)
Local control during Phase 2
Failures will be classified as local failures if failing within or immediately adjacent to the PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within a planning target volume but across a fissure).
Measured: 2 years
Overall survival
Length of time start of treatment that patients are still alive
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start20 Oct 2017
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Why it stopped: After completion of Phase I, it was decided not to initiate Phase II of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma. \*The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Lautenschlaeger, Indiana University
- Investigators
- Tim Lautenschlaeger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321747
- Sponsor's protocol ID
- IUSCC-0624
- Status last verified
- Jul 2022
- First submitted
- 23 Oct 2017
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT03321747
- Acronym / sponsor ID
- IUSCC-0624
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After completion of Phase I, it was decided not to initiate Phase II of the study.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 26 Oct 2017 (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.
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.
Detailed description
- Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung. During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung.
- Phase II Secondary Objectives
- Determine overall survival, progression free survival and patterns of failure after SABR.
- Determine tolerability of dose escalated SABR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma. *The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.
| Arm | Type | Receives |
|---|---|---|
| Phase 1/Dose Level 1 | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR)11 Gy will be given in 5 fractions for a total dose of 55 Gy |
| Phase 1/Dose Level 2 | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR)12 Gy will be given in 5 fractions for a total dose of 60 Gy |
| Phase 1/Dose Level 3 | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR)13 Gy will be given in 5 fractions for a total dose of 65 Gy |
| Phase 1/Dose Level 4 | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR)14 Gy will be given in 5 fractions for a total dose of 70 Gy |
| Phase 2 | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR)The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 at time of consent.
- Ability to provide written informed consent and HIPAA authorization.
- Pathological diagnosis of squamous cell carcinoma of the lung.
- Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).
- Tumors < 7cm
Key exclusion criteria (4 listed)
- Previous radiation therapy to the lung per investigator discretion.
- Inability to comply with treatment per investigator discretion.
- Inability to follow standard of care follow up recommendations per investigator discretion.
- KPS<40
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 |
|---|---|---|
| Stereotactic Ablative Body Radiation (SABR)Treatments shall not be delivered more frequently than every other day. | Radiation | Phase 1/Dose Level 1, Phase 1/Dose Level 2, Phase 1/Dose Level 3, Phase 1/Dose Level 4, Phase 2 |
Primary outcome
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
Time frame: 30 days
Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.
2 secondary outcomes
Local control during Phase 2
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: After completion of Phase I, it was decided not to initiate Phase II of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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.
Tim Lautenschlaeger, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Ablative Body Radiation (SABR) in people with Lung Cancer, run by Indiana University at 3 sites in United States.
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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After completion of Phase I, it was decided not to initiate Phase II of the study.). Results are not available in the source record.
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?
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1 (time frame: 30 days). 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 26 Jul 2022.