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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09313 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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<75 % participation
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To learn if using MRI (magnetic resonance imaging) to guide radiation therapy can help to control central lung cancer. The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study.
Primary Objective:
Stage I: Assess the feasibility of SMART for central lung tumors with simulated online adaptive planning.
Stage II: Evaluate the feasibility and safety of SMART in central lung tumors treated with 50Gy in 4-5 fractions.
Secondary Objectives:
Stage I: Determine clinical features that predict for greater benefit from adaptive planning Stage I: Determine the potential dosimetric benefit of SMART for central lung tumor Stage II: Determine the safety and efficacy of SMART for central lung tumors treated with 50Gy in 4-5 fractions.
Exploratory objectives:
Validate cine imaging and motion management strategies on the MR-linac
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I-(Simulated Online Adaptive Planning) | Experimental | Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans. |
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| Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) | Experimental | Participants will receive treatment with the investigational MRI-guided radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulated Online Adaptive Planning | Other | The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks | through study completion, an average of 1 year |
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Stage I:
Inclusion Criteria:
Exclusion Criteria:
Stage 2:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saumil Gandhi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M. D. Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2023 | Nov 6, 2025 |
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| Stereotactic MRI-guided adaptive radiotherapy-SMART | Radiation | The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study |
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| ICF_001.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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