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Geriatric Assessment for Lung Cancer

N/A

Recruiting

Led By Arya Amini

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Any patient with unresectable non-small cell lung cancer diagnosis who is 60 years of age or older and must be treated at the participating site

Patients who are receiving approved cancer treatment in combination or sequentially with radiation including hypofractionated radiation (45-60Gy in 15-20 fractions) are eligible

Must not have

More than one metastatic site: Examples: brain and adrenal, adrenal and liver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after completion of adjuvant treatment (12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a geriatric assessment can reduce chemotherapy radiation toxicity, improve quality of life & reduce decline in older lung cancer patients.

Who is the study for?

This trial is for older adults (60+) with unresectable non-small cell lung cancer planning to start a new treatment regimen within 4-6 weeks. It's open to those who can consent or have a proxy, understand English (or Spanish/Mandarin with available translation), and are treated at the participating site. Excluded are patients with planned surgery within 3 months, more than one metastatic site, or symptomatic brain metastases.

What is being tested?

The study compares geriatric assessment-directed recommendations versus usual care in managing chemotherapy radiation therapy for older NSCLC patients. It aims to identify risk factors, reduce toxicity and functional decline, and improve quality of life by informing physicians' treatment decisions through comprehensive assessments.

What are the potential side effects?

While specific side effects aren't listed as this trial focuses on assessment methods rather than drugs, typical chemotherapy radiation side effects may include fatigue, nausea, hair loss, increased infection risk and potential impact on organ function.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 or older with non-small cell lung cancer that cannot be surgically removed.

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I am currently undergoing approved cancer treatment with radiation.

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I have a single cancer spread outside the radiation area, like in the brain, lung, or adrenal gland.

Exclusion Criteria

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

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My cancer has spread to more than one part of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after completion of adjuvant treatment (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after completion of adjuvant treatment (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after completion of adjuvant treatment (12 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 3-5 non-hematologic toxicities

Secondary study objectives

Function

Hospitalizations/emergency department visit rates

Incidence of adverse events from durvalumab

+10 more

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

Active Control

Group I: Arm I (GA intervention)Experimental Treatment5 Interventions

Patients complete a geriatric assessment. Patients and physicians receive the geriatric assessment summary and assessment-based recommendations, which are provided prior to beginning chemotherapy and radiation, at the midpoint of chemotherapy and radiation treatment, and at the end of treatment. Patients also undergo blood and stool sample collection during screening and on study.

Group II: Arm II (usual care)Active Control5 Interventions

Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams, per usual care. Patients also undergo blood and stool sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 4Eligibility criteria met