Lung Cancer
Conditions
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.
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
Interventions
OTHERSimulated 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
RADIATIONStereotactic 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
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage I: Inclusion Criteria: 1. Primary lung cancer or lung metastasis from another primary 2. 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 3. Age ≥ 18 years 4. Ability to understand and the willingness to sign a written informed consent
Exclusion criteria
1. 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 2. Inability to tolerate MR imaging (Ie. history of claustrophobia) 3. 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: 1. Primary lung cancer or lung metastasis from another primary 2. 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 3. Age ≥ 18 years 4. Ability to understand and the willingness to sign a written informed consent 5. Determined by two thoracic radiation oncologists to require \> 10-15 fraction regimens if treated with CT-based, non-adaptive radiation therapy
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed