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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after completion of adjuvant treatment (12 months)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Incidence of grade 3-5 non-hematologic toxicities

Secondary outcome measures

Function

Hospitalizations/emergency department visit rates

Incidence of adverse events from durvalumab

+10 more

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 2

~1700

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

569 Previous Clinical Trials

1,924,508 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,191 Total Patients Enrolled

Arya AminiPrincipal InvestigatorCity of Hope Medical Center

5 Previous Clinical Trials

138 Total Patients Enrolled

Frequently Asked Questions

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

Is there availability for new participants in this clinical trial?

"The records hosted on clinicaltrials.gov show that this medical trial, which was initially posted in December of 2023, is not actively recruiting anymore. However, there are a plethora of other studies seeking participants at present with 2124 active trials overall."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

2024. "Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139627.