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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02280 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0071 | Other Identifier | M D Anderson Cancer Center | |
| 1R01HL157273-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.
PRIMARY OBJECTIVE:
I.To longitudinally assess cardiac injury (serum biomarkers, and grade >=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-NSCLC patients receiving chemoradiation.
OUTLINE:
Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.
After completion of study treatment, patients are followed up annually for up to 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment Plan (Cohort One) | Experimental | Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT. |
|
| Model Based Personalized Treatment Plan (Cohort Two) | Experimental | Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 Minute Walk Functional Test | Procedure | Participate in 6 MWT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in level of hs-TnT >= 5ng/L | Baseline up to end or chemoradiation (CRT) | up to 24 months |
| Incidence of grade >= 2 cardiovascular events | Defined by Common Terminology Criteria for Adverse Events version 5.0. | Within 12-month of completion of CRT] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall cardiac fitness | Assessed using 6 minute walk test. | Up to 24 months after CRT |
| EuroQol 5 Dimension 5 Level: Patient reported outcomes | Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongxing Liao, MD | Contact | 832-829-5312 | zliao@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Zhongxing Liao, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD 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 | Nov 11, 2024 | Mar 4, 2025 |
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| Biospecimen Collection | Procedure | Undergo blood and urine sample collection |
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| Computed Tomography | Procedure | Undergo SPECT/CT |
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| Echocardiography | Procedure | Undergo echocardiogram |
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| Exercise Cardiac Stress Test | Procedure | Undergo stress test |
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| Questionnaire Administration | Other | Complete questionnaires |
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| Single Photon Emission Computed Tomography | Procedure | Undergo SPECT/CT |
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| Up to 24 months after CRT |
| MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes | Score Range 0-10 (0) No symptom and (10) worst symptoms | Up to 24 months after CRT |
| Overall survival | Up to 10 years |
| ICF_000.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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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D014965 | X-Rays |
| D017785 | Photons |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D004601 | Elementary Particles |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |
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