Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stage I-(Simulated Online Adaptive Planning) Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans. |
Other: Simulated Online Adaptive Planning
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
|
| Experimental: Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) Participants will receive treatment with the investigational MRI-guided radiation therapy. |
Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Stage I:
Inclusion Criteria:
-
Primary lung cancer or lung metastasis from another primary
-
Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve
-
Age ≥ 18 years
-
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
-
Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices
-
Inability to tolerate MR imaging (Ie. history of claustrophobia)
-
Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Stage 2:
Inclusion Criteria:
-
Primary lung cancer or lung metastasis from another primary
-
Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve
-
Age ≥ 18 years
-
Ability to understand and the willingness to sign a written informed consent
-
Determined by two thoracic radiation oncologists to require > 10-15 fraction regimens if treated with CT-based, non-adaptive radiation therapy
Exclusion Criteria:
-
Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices
-
Inability to tolerate MR imaging (Ie. history of claustrophobia)
-
Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M. D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Saumil Gandhi, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0371
- NCI-2022-09313