Lung CancerNCT04507828
Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall
A study testing Treatment Planning using the DIBH Technique in people with Lung Cancer and Metastatic Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new radiation planning and treatment delivery technique called Deep Inspiration Breath Hold (DIBH) and expiration technique. This technique will be used to treat patients who have tumors close to the chest wall and are candidates for Stereotactic Body Radiation Therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastatic Cancer
- What is being tested?
- Treatment Planning using the DIBH Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2020to 30 Dec 2024
- 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
- Age≥ 18 at time of consent
- Karnofsky Performance Status (KPS) > 40
- Ability to provide written informed consent and HIPAA authorization
- Clinical or pathological diagnosis of primary lung cancer or metastasis to the lung
- Tumors must be located within 2 cm from the chest wall, defined as the inner border of the 2-cm lung expansion volume (per TG101)
- Plan to receive Lung SBRT
Who cannot join
- Patients with tumors with > 50% overlap between respiratory states based on CT simulation will not be eligible for this study
- Previous radiation therapy to the same site per investigator discretion
- Inability to comply with treatment or standard of care follow up per investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital / IU Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to evaluate a new radiation planning and treatment delivery technique called Deep Inspiration Breath Hold (DIBH) and expiration technique. This technique will be used to treat patients who have tumors close to the chest wall and are candidates for Stereotactic Body Radiation Therapy (SBRT). This study will assess the reduction of radiation to the chest wall during treatment using this technique.
Read the detailed description
Multiple studies have evaluated the efficacy of SBRT in patients with early stage lung cancer. The original Indiana University phase II trial evaluating three fraction SBRT with a total dose of 60-66 Gy for T1 and T2 (<7cm) lesions and median follow up of 50.2 months revealed a 3-year local failure rate of 5.7%. Tumor size and location did not impact tumor recurrence. [3]. RTOG 0236, which was a multi-institutional phase II trial evaluating the efficacy of three fraction SBRT for patients with peripherally located tumors, reported that 3-year local control rate was 98% with a median overall survival of 4 years and overall survival at 3 years of 56%. Long- term results of RTOG 0236 revealed a 5-year local failure rate of 7% and a 5-year overall survival rate of 40% [4, 5]. In addition, a pooled analysis of two randomized trials (Randomized study to Compare CyberKnife to Surgical Resection in Stage I Non-small Cell Lung Cancer [STARS] and the Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage [IA] Lung Cancer [ROSEL]) comparing SBRT vs. lobectomy for operable stage I (T1-2aN0M0) NSCLC showed a 3-year overall survival for SBRT of 95% and for surgery of 79% (HR=0.14, p=0.037). There was no statistically significant difference between both groups in terms of 3-year rate of recurrence-free survival (HR = 0.69, p = 0.54) [5]. To evaluate the efficacy of SBRT (66 Gy in 3 fractions) compared to standard treatment (70 Gy in 35 fractions), 102 patients, with stage I inoperable NSCLC, were randomized to each treatment arm in the SPACE trial. The results were consistent with similar overall survival and progression free survival on both treatment groups. According to the TROG 09.02 CHISEL trial, stage I inoperable NSCLC patients treated with SBRT had superior local control of the primary disease (HR: 0.32) without an increase in major toxicity compared to patients treated with standard fractionation[6].
Pulmonary metastases frequently happen in patients with different types of cancer. Around 50% of patients who suffer from malignancy-related mortality have pulmonary metastasis at the time of autopsy [7]. In 1995, Hellman et al introduced the concept of oligometastases and the importance of aggressive surgical or ablative therapies to improve overall survival in this population [8]. As a result, SBRT technique has been widely used to treat pulmonary metastases. Multiple studies have evaluated this technique including a retrospective study evaluating 577 patients who undergo SBRT for pulmonary metastases that revealed 5-year local control of 46.3% and 5-year overall survival of 21.8% [9]. Based on the above findings, the researchers propose a prospective feasibility trial evaluating the combined DIBH-expiration planning and delivery technique in patients with lung tumors in close proximity to the chest wall who are candidates to receive lung SBRT per their standard care.
Based on the observed respiration dependent movement during CT simulation the study team will assign patients into two cohorts: A) Tumors with no overlap between respiratory states and B) Tumors with up to 50% overlap between respiratory states. For A, the study team will have a composite plan delivering half the dose using DIBH plan and the other half using the expiration phase plan for each fraction. For B) the radiation target will be subdivided into different zones with different zones receiving different prescriptions. The study plan will be compared to a standard plan specifically designed for the same patient. Researchers hypothesize that this technique will enable us to reduce chest wall V30 by 50% and deliver 54 Gy in 3 fractions while meeting all the dosimetric constraints. Cohorts A and B will be analyzed separately. Other dosimetric parameters will be evaluated in this trial.
- Conditions
- Lung Cancer, Metastatic Cancer
- Being tested
- Treatment Planning using the DIBH Technique
- Keywords
- Radiation Treatment, Lung Cancer, Metastatic Cancer, Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Planning using the DIBH TechniqueRadiation
Different radiation plans will be generated-one using a DIBH scan with corresponding target and normal tissue contour and a second using an expiration scan with corresponding target and normal tissue contours. The expiration scan can be an expiratory gating scan averaging the expiratory breathing phases or an expiration breath hold scan as determined based on patient performance during simulation and relative tumor displacement compared to the DIBH scan. Then a third plan will be generated conceptually combining the two previous plans, named the DIBH-expiration composite plan.
| Study group | Role | What they receive |
|---|---|---|
| Combined DIBH-Expiration Planning Technique | Experimental | Patients will undergo a 4D scan as well as a DIBH scan and an expiration breath hold scan. In order to develop a combined DIBH-Expiration treatment plan, the DIBH scan, the expiration phase of the 4D scan or the expiration breath hold scan will be used. If the radiation plan meets the coverage goals and normal tissue constraints, the patient will receive treatment using the new DIBH Planning Technique. If coverage and normal tissue constraints are not met per protocol, the patient will be treated per standard of care and not on protocol. Patients treated on protocol will undergo radiation treatment with SBRT for a total of 3 fractions and will receive each fraction no more frequently then every other day. Patients will then be evaluated at 1 month after SBRT completion and every 3 months for 2 years Receives: Radiation: Treatment Planning using the DIBH Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in chest wall V30 using combined DIBH-expiration planning technique
The percentage of patients with an at least 50% reduction in chest wall V30 using combined DIBH-expiration planning technique in comparison to DIBH or expiration gating alone in the same patient
Measured: 2 weeks (SBRT planning)
Secondary outcomes (7)
Patients treated using DIBH planning technique
Percentage of patients treated with 54 Gy in 3 fractions using our new technique, who did not meet constraints for three fraction treatments using standard planning delivery techniques
Measured: 8 weeks (treatment with SBRT)
Chest wall toxicity
Incidence of chest wall toxicity
Measured: 1 year
Rib fracture
Incidence of rib fracture (based on surveillance imaging)
Measured: 1 year
Local control rate
local control rates (defined as no tumor recurrence within 80% isodose line)
Measured: 2 year
Time in treatment room
Amount of on-table time in treatment room
Measured: 8 weeks (completion of SBRT)
Reduction in chest wall maximum dose
The calculated mean average of dosimetric reduction in chest wall maximum dose
Measured: 2 weeks (SBRT planning)
Evaluate lung dose
Evaluation of mean lung dose
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start2 Oct 2020
- Primary completion16 Feb 2023
- Study completion30 Dec 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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 Lautenschlager, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507828
- Sponsor's protocol ID
- RAON-IIR-IUSCC-0711
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall
- ClinicalTrials.gov ID
- NCT04507828
- Acronym / sponsor ID
- RAON-IIR-IUSCC-0711
- Conditions
- Lung Cancer, Metastatic Cancer
- Keywords
- Radiation Treatment, Lung Cancer, Metastatic Cancer, Stereotactic Body Radiation Therapy (SBRT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 11 Aug 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.
The purpose of this study is to evaluate a new radiation planning and treatment delivery technique called Deep Inspiration Breath Hold (DIBH) and expiration technique. This technique will be used to treat patients who have tumors close to the chest wall and are candidates for Stereotactic Body Radiation Therapy (SBRT). This study will assess the reduction of radiation to the chest wall during treatment using this technique.
Detailed description
Multiple studies have evaluated the efficacy of SBRT in patients with early stage lung cancer. The original Indiana University phase II trial evaluating three fraction SBRT with a total dose of 60-66 Gy for T1 and T2 (<7cm) lesions and median follow up of 50.2 months revealed a 3-year local failure rate of 5.7%. Tumor size and location did not impact tumor recurrence. [3]. RTOG 0236, which was a multi-institutional phase II trial evaluating the efficacy of three fraction SBRT for patients with peripherally located tumors, reported that 3-year local control rate was 98% with a median overall survival of 4 years and overall survival at 3 years of 56%. Long- term results of RTOG 0236 revealed a 5-year local failure rate of 7% and a 5-year overall survival rate of 40% [4, 5]. In addition, a pooled analysis of two randomized trials (Randomized study to Compare CyberKnife to Surgical Resection in Stage I Non-small Cell Lung Cancer [STARS] and the Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage [IA] Lung Cancer [ROSEL]) comparing SBRT vs. lobectomy for operable stage I (T1-2aN0M0) NSCLC showed a 3-year overall survival for SBRT of 95% and for surgery of 79% (HR=0.14, p=0.037). There was no statistically significant difference between both groups in terms of 3-year rate of recurrence-free survival (HR = 0.69, p = 0.54) [5]. To evaluate the efficacy of SBRT (66 Gy in 3 fractions) compared to standard treatment (70 Gy in 35 fractions), 102 patients, with stage I inoperable NSCLC, were randomized to each treatment arm in the SPACE trial. The results were consistent with similar overall survival and progression free survival on both treatment groups. According to the TROG 09.02 CHISEL trial, stage I inoperable NSCLC patients treated with SBRT had superior local control of the primary disease (HR: 0.32) without an increase in major toxicity compared to patients treated with standard fractionation[6].
Pulmonary metastases frequently happen in patients with different types of cancer. Around 50% of patients who suffer from malignancy-related mortality have pulmonary metastasis at the time of autopsy [7]. In 1995, Hellman et al introduced the concept of oligometastases and the importance of aggressive surgical or ablative therapies to improve overall survival in this population [8]. As a result, SBRT technique has been widely used to treat pulmonary metastases. Multiple studies have evaluated this technique including a retrospective study evaluating 577 patients who undergo SBRT for pulmonary metastases that revealed 5-year local control of 46.3% and 5-year overall survival of 21.8% [9]. Based on the above findings, the researchers propose a prospective feasibility trial evaluating the combined DIBH-expiration planning and delivery technique in patients with lung tumors in close proximity to the chest wall who are candidates to receive lung SBRT per their standard care.
Based on the observed respiration dependent movement during CT simulation the study team will assign patients into two cohorts: A) Tumors with no overlap between respiratory states and B) Tumors with up to 50% overlap between respiratory states. For A, the study team will have a composite plan delivering half the dose using DIBH plan and the other half using the expiration phase plan for each fraction. For B) the radiation target will be subdivided into different zones with different zones receiving different prescriptions. The study plan will be compared to a standard plan specifically designed for the same patient. Researchers hypothesize that this technique will enable us to reduce chest wall V30 by 50% and deliver 54 Gy in 3 fractions while meeting all the dosimetric constraints. Cohorts A and B will be analyzed separately. Other dosimetric parameters will be evaluated in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined DIBH-Expiration Planning Technique | Experimental | Radiation: Treatment Planning using the DIBH TechniquePatients will undergo a 4D scan as well as a DIBH scan and an expiration breath hold scan. In order to develop a combined DIBH-Expiration treatment plan, the DIBH scan, the expiration phase of the 4D scan or the expiration breath hold scan will be used. If the radiation plan meets the coverage goals and normal tissue constraints, the patient will receive treatment using the new DIBH Planning Technique. If coverage and normal tissue constraints are not met per protocol, the patient will be treated per standard of care and not on protocol. Patients treated on protocol will undergo radiation treatment with SBRT for a total of 3 fractions and will receive each fraction no more frequently then every other day. Patients will then be evaluated at 1 month after SBRT completion and every 3 months for 2 years |
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 at time of consent
- Karnofsky Performance Status (KPS) > 40
- Ability to provide written informed consent and HIPAA authorization
- Clinical or pathological diagnosis of primary lung cancer or metastasis to the lung
- Tumors must be located within 2 cm from the chest wall, defined as the inner border of the 2-cm lung expansion volume (per TG101)
Key exclusion criteria (3 listed)
- Patients with tumors with > 50% overlap between respiratory states based on CT simulation will not be eligible for this study
- Previous radiation therapy to the same site per investigator discretion
- Inability to comply with treatment or standard of care follow up per investigator discretion
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 |
|---|---|---|
| Treatment Planning using the DIBH TechniqueDifferent radiation plans will be generated-one using a DIBH scan with corresponding target and normal tissue contour and a second using an expiration scan with corresponding target and normal tissue contours. The expiration scan can be an expiratory gating scan averaging the expiratory breathing phases or an expiration breath hold scan as determined based on patient performance during simulation and relative tumor displacement compared to the DIBH scan. Then a third plan will be generated conceptually combining the two previous plans, named the DIBH-expiration composite plan. | Radiation | Combined DIBH-Expiration Planning Technique |
Primary outcome
Reduction in chest wall V30 using combined DIBH-expiration planning technique
Time frame: 2 weeks (SBRT planning)
The percentage of patients with an at least 50% reduction in chest wall V30 using combined DIBH-expiration planning technique in comparison to DIBH or expiration gating alone in the same patient
7 secondary outcomes
Patients treated using DIBH planning technique
Time frame: 8 weeks (treatment with SBRT)
Chest wall toxicity
Time frame: 1 year
Rib fracture
Time frame: 1 year
Local control rate
Time frame: 2 year
Time in treatment room
Time frame: 8 weeks (completion of SBRT)
Reduction in chest wall maximum dose
Time frame: 2 weeks (SBRT planning)
Evaluate lung dose
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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 Lautenschlager, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Planning using the DIBH Technique in people with Lung Cancer and Metastatic Cancer, run by Indiana University at 1 site 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 1 Apr 2025. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in chest wall V30 using combined DIBH-expiration planning technique (time frame: 2 weeks (SBRT planning)). 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 1 Apr 2025.