~18 spots leftby Feb 2026

Personalized Chemoradiation for Lung Cancer

Recruiting in Palo Alto (17 mi)
ZL
Overseen byZhongxing Liao
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnancy, Renal failure, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Model Based Personalized Chemoradiation, Tecentriq, MPDL3280A, RG7446 for lung cancer?

Research suggests that personalized radiotherapy, which tailors treatment to the specific characteristics of a patient's tumor, can improve outcomes in lung cancer. Additionally, tools like the Radiotherapy Outcomes Estimator help optimize radiotherapy prescriptions, potentially enhancing the effectiveness of treatments like Model Based Personalized Chemoradiation.12345

Is Personalized Chemoradiation for Lung Cancer safe for humans?

The research on similar treatments, like chemoradiotherapy combined with other drugs, shows that they generally have a manageable safety profile, but the specific safety of Personalized Chemoradiation for Lung Cancer would need to be confirmed in its own studies.46789

What makes the treatment Model Based Personalized Chemoradiation unique for lung cancer?

This treatment is unique because it combines personalized chemotherapy and radiation therapy, potentially using Tecentriq (an immunotherapy drug) to enhance the effectiveness of radiation by targeting specific molecular pathways in the tumor, which may improve outcomes for patients with hard-to-treat lung cancer.1011121314

Research Team

ZL

Zhongxing Liao

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with locally advanced non-small cell lung cancer who can sign consent, undergo thoracic radiation and systemic therapy (like chemo), and perform cardiac tests. They must have a Karnofsky performance status of 70 or above, indicating they are able to care for themselves. Excluded are those with prior chest radiation, pregnant or breastfeeding women, renal failure patients on dialysis, or anyone unable to do the required heart imaging tests.

Inclusion Criteria

I am willing and able to undergo heart imaging tests.
I am able to care for myself but may not be able to do active work.
I have been diagnosed with non-small cell lung cancer.
See 4 more

Exclusion Criteria

I have had radiation therapy to my chest area before.
I am on dialysis due to kidney failure.
I cannot do the tests required by the study.
See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy (RT)

Participants undergo SPECT/CT with stress test and echocardiogram with strain before RT, and participate in 6 MWT before RT, 2-3 and 6-7 weeks during RT

6-7 weeks

Chemoradiation (CRT)

Participants receive chemoradiation treatment and 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

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including SPECT/CT with stress test and echocardiogram with strain, 6 MWT, and blood sample collection at 6-8 weeks, 4-6 months, 12 months, and annually up to 10 years

Up to 10 years

Treatment Details

Interventions

  • Model Based Personalized Chemoradiation (Chemotherapy)
Trial OverviewThe trial is studying how personalized chemoradiation treatment affects heart health in lung cancer patients. It involves various cardiac fitness assessments like walking tests and heart scans using techniques such as SPECT and echocardiography before and after treatment to see if tailoring therapy based on individual risk can protect the heart.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard Treatment Plan (Cohort One)Experimental Treatment7 Interventions
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.
Group II: Model Based Personalized Treatment Plan (Cohort Two)Experimental Treatment7 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+
Dr. Peter WT Pisters profile image

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee profile image

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+
Dr. Gary H. Gibbons profile image

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley profile image

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

The ROE software tool allows for personalized radiotherapy prescriptions by visualizing tumor control and normal tissue complications based on patient-specific dose-response curves, enhancing treatment planning.
This open-source tool can improve patient understanding of treatment risks and benefits, assess dose escalation potential, and estimate accrual rates for new protocols, making it a valuable resource in clinical settings.
ROE (Radiotherapy Outcomes Estimator): An open-source tool for optimizing radiotherapy prescriptions.Iyer, A., Apte, AP., Bendau, E., et al.[2023]
Current radiotherapy doses are often based on traditional methods rather than scientific evidence, leading to a one-size-fits-all approach that may not suit all patients' needs.
Personalizing radiotherapy using genomic biomarkers can enhance treatment effectiveness by tailoring doses to the specific radiosensitivity of tumors, potentially improving patient outcomes in terms of control and cure rates.
Novel Genomic-Based Strategies to Personalize Lymph Node Radiation Therapy.Oliver, DE., Mohammadi, H., Figura, N., et al.[2019]
The proPED-LUNG platform has successfully enrolled 315 lung cancer patients over 18 months, demonstrating high compliance rates (96-100% for patient-rated and 81-94% for physician-rated assessments) for collecting comprehensive data on treatment outcomes and quality of life.
This prospective platform enables multidimensional predictive modeling by gathering extensive baseline and follow-up data, which can help evaluate and improve new radiotherapy options for lung cancer treatment.
An instrument dedicated for modelling of pulmonary radiotherapy.Niezink, AG., Dollekamp, NJ., Elzinga, HJ., et al.[2018]

References

ROE (Radiotherapy Outcomes Estimator): An open-source tool for optimizing radiotherapy prescriptions. [2023]
Novel Genomic-Based Strategies to Personalize Lymph Node Radiation Therapy. [2019]
An instrument dedicated for modelling of pulmonary radiotherapy. [2018]
Effects of EGFR driver mutations on pathologic regression in resectable locally advanced non-small cell lung cancer treated with neoadjuvant chemoradiation and completion surgery. [2023]
Patient-Derived Tumoroid for the Prediction of Radiotherapy and Chemotherapy Responses in Non-Small-Cell Lung Cancer. [2023]
Prospective study of epidermal growth factor receptor tyrosine kinase inhibitors concurrent with individualized radiotherapy for patients with locally advanced or metastatic non-small-cell lung cancer. [2018]
Intensified high-dose chemoradiotherapy with induction chemotherapy in patients with locally advanced non-small-cell lung cancer-safety and toxicity results within a prospective trial. [2018]
Radiopotentiation Profiling of Multiple Inhibitors of the DNA Damage Response for Early Clinical Development. [2022]
Phase I Trial of Definitive Concurrent Chemoradiotherapy and Trametinib for KRAS-Mutated Non-Small Cell Lung Cancer. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Integrative Pharmacogenomics Analysis of Patient-Derived Xenografts. [2019]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
Establishing a colorectal cancer liver metastasis patient-derived tumor xenograft model for the evaluation of personalized chemotherapy. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Screening and Validation of Molecular Targeted Radiosensitizers. [2022]
Integrative oncology drug discovery accompanied by preclinical translational research as prerequisite for clinical development. [2015]
Establishment of a platform of non-small-cell lung cancer patient-derived xenografts with clinical and genomic annotation. [2019]