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Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulated Online Adaptive Planning
Stereotactic MRI-guided adaptive radiotherapy-SMART
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M. D. Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stage I-(Simulated Online Adaptive Planning)

Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)

Arm Description

Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.

Participants will receive treatment with the investigational MRI-guided radiation therapy.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
May 11, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05609331
Brief Title
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
Official Title
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
January 7, 2024 (Anticipated)
Study Completion Date
January 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage I-(Simulated Online Adaptive Planning)
Arm Type
Experimental
Arm Description
Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.
Arm Title
Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)
Arm Type
Experimental
Arm Description
Participants will receive treatment with the investigational MRI-guided radiation therapy.
Intervention Type
Other
Intervention Name(s)
Simulated Online Adaptive Planning
Intervention Description
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Intervention Type
Radiation
Intervention Name(s)
Stereotactic MRI-guided adaptive radiotherapy-SMART
Intervention Description
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Primary Outcome Measure Information:
Title
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saumil Gandhi, MD
Phone
(713) 563-7775
Email
sngandhi@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi, MD
First Name & Middle Initial & Last Name & Degree
Saumil Gandhi, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M. D. Anderson Cancer Center

Learn more about this trial

Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors

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