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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of grade >= 2 cardiovascular events

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

Secondary outcome measures

EuroQol 5 Dimension 5 Level: Patient reported outcomes

MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes

Overall cardiac fitness

+1 more

Side effects data

From 2012 Phase 2 trial • 124 Patients • NCT01334918

15%

Flushing

13%

Headache

11%

Dyspnoea

Chest discomfort

Dizziness

Nausea

Angina pectoris

Gastritis

100%

80%

60%

40%

20%

Study treatment Arm

SPECT

MDCT

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

~310

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,554 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,246 Total Patients Enrolled

Zhongxing LiaoPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

430 Total Patients Enrolled

Media Library

Model Based Personalized Chemoradiation (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05010109 — Phase 1

Lung Carcinoma Research Study Groups: Standard Treatment Plan (Cohort One), Model Based Personalized Treatment Plan (Cohort Two)

Lung Carcinoma Clinical Trial 2023: Model Based Personalized Chemoradiation Highlights & Side Effects. Trial Name: NCT05010109 — Phase 1

Model Based Personalized Chemoradiation (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010109 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are contributing to this clinical exploration?

"Yes, according to the information present on clinicaltrials.gov, this medical study is currently enlisting participants. Initially posted in July 5th 2021 and last edited November 2nd 2022, 100 individuals from one site need to be recruited for the trial."

Answered by AI

Has the FDA sanctioned Single Photon Emission Computed Tomography as a viable medical imaging technique?

"As a Phase 1 trial, there is limited evidence for the safety of Single Photon Emission Computed Tomography; our team at Power thus awarded it a score of 1."

Answered by AI

Are there still available slots in this scientific investigation?

"Affirmative. The information on clinicaltrials.gov verifies that this research project is still recruiting patients, having been posted in July 2021 and most recently revised in November 2022. 100 participants are being sought from 1 participating institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

2021. "Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010109.