Non-Small Cell Lung CancerNCT02950792
MRI Adaptive Replanning Using ViewRay
A study testing ViewRay MRI and Stereotactic Body Radiation Therapy Boost in people with Non-Small Cell Lung Cancer, run by University of Miami at 1 site in United States.
Trial summary
Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- ViewRay MRI and Stereotactic Body Radiation Therapy Boost
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2017to 8 Aug 2017
- 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
- Patient must have primary lung tumor identified on MRI, histologically proven to be NSCLC.
- Patients must be clinical AJCC stage IIIA or IIIB (AJCC 7th ed) with non-operable disease; evaluated by a multidisciplinary treatment team including at least 1 thoracic surgeon within 8 weeks prior to registration.
- Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible
- Minimum diagnostic workup to include:
- History/physical examination, including documentation of weight, within 8 weeks prior to registration (2 weeks optimal)
- Diagnostic CT scan for staging and RT plan within 4 weeks prior to registration;
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- CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
- CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
- Able to tolerate repeated MRI imaging
- Pulmonary function tests, including diffusing capacity of the lung for carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in one second (FEV1) ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
- Zubrod Performance Status 0-1 within 2 weeks prior to registration
- Age ≥ 18;
- Complete blood count (CBC)/differential obtained no more than 8 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- White blood cell (WBC) ≥ 4000/ml
- Absolute neutrophil count (ANC) ≥1,800 cells/mm
- Platelets ≥100,000 cells/mm
- Hemoglobin ≥ 10.0 mg/dl (Note: the use of transfusion or other intervention to achieve this level is acceptable)
- Serum creatinine, blood urea nitrogen, alanine aminotransferase (ALT), aspartate aminotransferase (AST), Alk Phos, total bilirubin, serum electrolytes (eg. Sodium, potassium, chloride, bicarbonate, calcium), glucose, total protein, albumin will be drawn no greater than 8 weeks prior to enrollment.
- Serum creatinine of 1.5mg or less; serum bilirubin of 2.0mg or less; creatinine clearance of 60ml/min or greater no more than 4 weeks prior to registration (Note: calculated creatinine clearance is permissible. If the creatinine clearance is greater than 60ml/min, then a serum creatinine of up to 1.8mg is allowable at the discretion of the PI
- Serum pregnancy test for female patients of childbearing potential, ≤8 weeks prior to enrollment; women of childbearing potential and male participants must practice adequate contraception on trial
- Patients must be able to provide study-specific informed consent prior to study entry
- Patients must agree to have their biopsy tissue and blood banked for future molecular studies
Who cannot join
- Patients with any component of small cell lung carcinoma are excluded
- Evidence of distant metastases.
- Patients with evidence of a malignant pleural or pericardial effusion.
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease free for greater than or equal to five years except for nonmelanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix.
- Prior radiotherapy that would result in overlap of radiation fields
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- Patients taking drugs with potential nephrotoxicity or ototoxicity (such as aminoglycosides)
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Prior allergic reaction to the study drug(s) involved in this protocol
- Patients with T4 disease with radiographic evidence of invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.
- Severe active co-morbidity:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note: laboratory tests for liver function and coagulation parameters are not required for entry into this protocol)
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition (Note: HIV testing is not required for entry into this protocol) The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Adaptive Radiotherapy Using ViewRay MRI Based Imaging in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real time, online adaptive planning using magnetic resonance imaging (MRI) could achieve significant volume reduction of primary lung disease over the course of therapy, thereby reducing dose to normal structures, and providing a mechanism in which to dose escalate safely, and more effectively with accurate target delineation.
The investigators hypothesize that MRI based adaptive planning will provide a novel method to dose escalate safely with acceptable organ at risk doses. In addition, further improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of target-tissue coverage will be achieved through the use of 4D real-time tracking which is derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography Simulator (CTsim) with advanced non-rigid image-registration tools.
Read the detailed description
This study is a single-arm phase II study of adaptive radiotherapy using ViewRay MRI based imaging in locally Advanced non-small cell lung cancer patients. Randomization is not applicable.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- ViewRay MRI, Stereotactic Body Radiation Therapy Boost
- Keywords
- Non-Small Cell Lung Cancer, NSCLC
- 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.
ViewRay MRIDevice
Also called ViewRay Magnetic Resonance Imaging
ViewRay Magnetic Resonance Imaging
Stereotactic Body Radiation Therapy BoostRadiation
Also called Stereotactic radiosurgery (SRS) Boost
In the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors < 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors < 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) < 20 Gy with V20 < 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs.
| Study group | Role | What they receive |
|---|---|---|
| ViewRay MRI-IGART | Experimental | ViewRay MRI-Image-Guided Adaptive Radiation Therapy (IGART):
* Daily MRI on ViewRay 5 days per week for 4 weeks in combination with weekly standard of care chemo-radiation.
* Daily MRI on ViewRay during Week 5 in combination with Stereotactic Body Radiation Therapy boost for daily for up to 1 week.
* Continued standard of care consolidation chemotherapy every 21 days for 3 cycles, beginning 4 - 6 weeks after completion radiation therapy, . Receives: Device: ViewRay MRI; Radiation: Stereotactic Body Radiation Therapy Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Locoregional Failure/Progression (LRF/LRP) in Study Participants Receiving Protocol Therapy.
MRI-based adaptative radiation planning can provide a method for dose escalation to improve locoregional Failure (LRF/LRP) rates at 2 years in study participants. Locoregional failure/progression (LRF/LRP) will be defined as development of progressive lung cancer centered within 1 cm from the initial planning target volume (PTV). Progressive disease in any of the 14 nodal stations will be considered as regional recurrence. Progression will be assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. with integration of MRI/CT.
Measured: Up to 2 Years After Protocol Therapy
Rate of Severe Treatment-Induced Toxicity
Rate of severe (grade 3 CTCAE, v.4) radiation-induced lung toxicity (RILT) and other severe adverse events, including grade 3+ (CTCAE, v.4) esophagitis, or grade 2 pericardial effusions, or any grade cardiac adverse events related to chemo-radiation using MRI-based adaptive planning vs. historical controls using conventional plans.
Measured: Up to 2 Years Post-End of Protocol Therapy
Secondary outcomes (6)
Rate of Overall Survival (OS) in Study Participants
Rate of overall survival in study participants using MRI-based adaptive planning vs historical controls. Overall survival is defined as the length of time from the start of treatment that study participants are still alive.
Measured: Up to 3 years after protocol therapy.
Rate of Progression-Free Survival (PFS) in Study Participants
Rate of progression-free survival in study participants using MRI-based adaptive planning vs historical controls. Progression-Free Survival (PFS) is defined as the length of time that passes from the start date of protocol therapy until the date on which disease "progresses" or the date on which the participant dies, from any cause. Disease progression will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
Measured: Up to 3 years after protocol therapy.
Rate of Lung Cancer-Specific Survival
Rate of Lung Cancer-specific survival in study participants using MRI-based adaptive planning vs historical controls. Lung cancer-specific survival is defined as the length of time that passes from the date of diagnosis or start date of protocol therapy until the date of death from lung cancer.
Measured: Up to 3 years after protocol therapy.
Comparison of Gross Tumor Volumes (GTV) defined by MRI vs. FanBeam CT (FBCT) at CT Simulation and at each adaptive planning time point.
Gross tumor volumes (GTVs) at a specific time point between MRI and Fan Bean CT will be compared using Mann-Whitney test.
Measured: Daily Up to 5 weeks after start of protocol therapy
Development of a Database consisting all Daily MR data sets to support further research.
Potential applications include determination of optimal adaptive planning frequency and the benefits of basing IGART on 4D anatomic datasets derived from deformably registering daily MR and planning FBCT and MR datasets.
Measured: Up to 5 years
Predictivity of Volumetric Changes in MRI Imaging for Locoregional failure/progression (LRP) and Organs at Risk (OARs) toxicity.
Predictivity of volumetric changes in MRI imaging for LRP and OAR toxicity will be assessed using time-dependent receiver operating characteristic (ROC) method and regular ROC method, respectively.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startAug 2017 (estimated)
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Why it stopped: Investigator Decision
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 University of MiamiThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Ishkanian, University of Miami
- Investigators
- Adrian Ishkanian, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950792
- Sponsor's protocol ID
- 20160397
- Status last verified
- Aug 2017
- First submitted
- 24 Oct 2016
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Adaptive Radiotherapy Using ViewRay MRI Based Imaging in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02950792
- Acronym / sponsor ID
- 20160397
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real time, online adaptive planning using magnetic resonance imaging (MRI) could achieve significant volume reduction of primary lung disease over the course of therapy, thereby reducing dose to normal structures, and providing a mechanism in which to dose escalate safely, and more effectively with accurate target delineation.
The investigators hypothesize that MRI based adaptive planning will provide a novel method to dose escalate safely with acceptable organ at risk doses. In addition, further improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of target-tissue coverage will be achieved through the use of 4D real-time tracking which is derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography Simulator (CTsim) with advanced non-rigid image-registration tools.
Detailed description
This study is a single-arm phase II study of adaptive radiotherapy using ViewRay MRI based imaging in locally Advanced non-small cell lung cancer patients. Randomization is not applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ViewRay MRI-IGART | Experimental | Device: ViewRay MRI, Radiation: Stereotactic Body Radiation Therapy BoostViewRay MRI-Image-Guided Adaptive Radiation Therapy (IGART): * Daily MRI on ViewRay 5 days per week for 4 weeks in combination with weekly standard of care chemo-radiation. * Daily MRI on ViewRay during Week 5 in combination with Stereotactic Body Radiation Therapy boost for daily for up to 1 week. * Continued standard of care consolidation chemotherapy every 21 days for 3 cycles, beginning 4 - 6 weeks after completion radiation therapy, . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient must have primary lung tumor identified on MRI, histologically proven to be NSCLC.
- Patients must be clinical AJCC stage IIIA or IIIB (AJCC 7th ed) with non-operable disease; evaluated by a multidisciplinary treatment team including at least 1 thoracic surgeon within 8 weeks prior to registration.
- Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible
- Minimum diagnostic workup to include:
Key exclusion criteria (17 listed)
- Patients with any component of small cell lung carcinoma are excluded
- Evidence of distant metastases.
- Patients with evidence of a malignant pleural or pericardial effusion.
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease free for greater than or equal to five years except for nonmelanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix.
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 |
|---|---|---|
| ViewRay MRIAlso: ViewRay Magnetic Resonance ImagingViewRay Magnetic Resonance Imaging | Device | ViewRay MRI-IGART |
| Stereotactic Body Radiation Therapy BoostAlso: Stereotactic radiosurgery (SRS) BoostIn the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors < 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors < 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) < 20 Gy with V20 < 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs. | Radiation | ViewRay MRI-IGART |
Primary outcome
Rate of Locoregional Failure/Progression (LRF/LRP) in Study Participants Receiving Protocol Therapy.
Time frame: Up to 2 Years After Protocol Therapy
MRI-based adaptative radiation planning can provide a method for dose escalation to improve locoregional Failure (LRF/LRP) rates at 2 years in study participants. Locoregional failure/progression (LRF/LRP) will be defined as development of progressive lung cancer centered within 1 cm from the initial planning target volume (PTV). Progressive disease in any of the 14 nodal stations will be considered as regional recurrence. Progression will be assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. with integration of MRI/CT.
Rate of Severe Treatment-Induced Toxicity
Time frame: Up to 2 Years Post-End of Protocol Therapy
Rate of severe (grade 3 CTCAE, v.4) radiation-induced lung toxicity (RILT) and other severe adverse events, including grade 3+ (CTCAE, v.4) esophagitis, or grade 2 pericardial effusions, or any grade cardiac adverse events related to chemo-radiation using MRI-based adaptive planning vs. historical controls using conventional plans.
6 secondary outcomes
Rate of Overall Survival (OS) in Study Participants
Time frame: Up to 3 years after protocol therapy.
Rate of Progression-Free Survival (PFS) in Study Participants
Time frame: Up to 3 years after protocol therapy.
Rate of Lung Cancer-Specific Survival
Time frame: Up to 3 years after protocol therapy.
Comparison of Gross Tumor Volumes (GTV) defined by MRI vs. FanBeam CT (FBCT) at CT Simulation and at each adaptive planning time point.
Time frame: Daily Up to 5 weeks after start of protocol therapy
Development of a Database consisting all Daily MR data sets to support further research.
Time frame: Up to 5 years
Predictivity of Volumetric Changes in MRI Imaging for Locoregional failure/progression (LRP) and Organs at Risk (OARs) toxicity.
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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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.
Adrian Ishkanian, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViewRay MRI and Stereotactic Body Radiation Therapy Boost in people with Non-Small Cell Lung Cancer, run by University of Miami 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 22 inclusion and 17 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: withdrawn, as of the sponsor's last update on 25 Aug 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 Locoregional Failure/Progression (LRF/LRP) in Study Participants Receiving Protocol Therapy. (time frame: Up to 2 Years After Protocol Therapy). The study lists 2 primary outcomes in all. 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 25 Aug 2017.