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Chemotherapy

Personalized Chemoradiation for Lung Cancer

Phase 1

Recruiting

Led By Zhongxing Liao

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able and willing to perform required cardiac imaging examinations

Patient with histologic diagnosis of non-small cell lung cancer

Must not have

Previous history of RT to the thorax

Renal failure necessitating dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is assessing whether personalized chemoradiation for lung cancer patients with locally advanced disease can reduce the risk of developing heart disease.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While not directly testing drug side effects, this study may involve typical risks associated with chemoradiation such as fatigue, nausea, skin changes at the radiation site; plus potential discomfort or complications from cardiac stress tests like shortness of breath or irregular heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to undergo heart imaging tests.

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I have been diagnosed with non-small cell lung cancer.

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I am able to care for myself but may not be able to do active work.

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I can and am willing to do a 6-minute walking test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my chest area before.

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I am on dialysis due to kidney failure.

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I cannot do the tests required by the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of grade >= 2 cardiovascular events

Increase in level of hs-TnT >= 5ng/L

Secondary study objectives

EuroQol 5 Dimension 5 Level: Patient reported outcomes

MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes

Overall cardiac fitness

Side effects data

From 2012 Phase 2 trial • 124 Patients • NCT01334918

15%

Flushing

13%

Headache

11%

Dyspnoea

Dizziness

Chest discomfort

Nausea

Angina pectoris

Gastritis

100%

80%

60%

40%

20%

Study treatment Arm

SPECT

MDCT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320

Computed Tomography

2017

Completed Phase 2