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

Stage III Lung Cancer AJCC v8 Clinical Trial

Official title:

Geriatric Assessment and Management (GAM) for Older Adults With Non-Small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy (GAM-CRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139627
• Other study ID #: 23398
• Secondary ID: NCI-2023-0714023
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2024
• Est. completion date: July 19, 2026

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.

Description:

PRIMARY OBJECTIVE:

I. To demonstrate if providing a GA summary and recommendations for GA-directed interventions to oncology care teams decreases the proportion of older adults with unresectable, stage III NSCLC who experience any grade 3-5 non-hematologic toxicity from chemotherapy and radiation.

SECONDARY OBJECTIVES:

I. To demonstrate the differences between the intervention versus usual care group among:

Ia. Overall grade 3-5 toxicities; Ib. Patient-reported symptomatic toxicities as measured by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PROCTCAE), Patient Reported Outcomes Measurement Information System - 10 (PROMIS-10); Ic. Implementation of GA recommendations; Id. GA outcomes including function (Activities of Daily Living/Instrumental Activities of Daily Living,), physical performance (Short Physical Performance Battery, 2 minute [min] walk, falls), polypharmacy (reduction in medication burden), mood (Geriatric Depression Scale 5/15 and PROMIS Anxiety short form 4a); Ie. Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC-QLQ-30]); If. Treatment sequencing (concurrent versus sequential) and completion, hospitalizations/emergency department (ED) rates.

EXPLORATORY OBJECTIVE:

I. To explore microbial diversity and blood components at baseline, and at 6 months from treatment initiation as a potential biomarker of treatment-related toxicity and disease response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study intervention, patients are followed up at 4-6 weeks, 10-14 weeks, and 20-26 weeks after baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 19, 2026
• Est. primary completion date: July 19, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• ONCOLOGY PHYSICIANS INCLUSION:

• Oncology physicians must work at the participating site with no plans to leave that site or retire at the time of enrollment into the study

• PATIENTS INCLUSION:

• 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

• Clinical staging without pathological confirmation of nodal disease is allowed

• Plan to start a new cancer treatment regimen within 4-6 weeks from time of baseline study visit. The treatment regimen is up to the discretion of the treating oncology physician. The regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity. This can be either concurrent or sequential with radiation therapy

• Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) will be allowed. Given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies

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

• Those patients with oligometastatic disease having only one site and one lesion outside of the radiation field will be eligible. Examples include a solitary brain metastasis (met), contralateral lung nodule or an adrenal metastatic site

• A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met

• Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit

• Participant or healthcare proxy has adequate understanding of the English language (preferred) because not all GA measures have been validated in other languages. Study team should be contacted for any participants with other preferred languages including Spanish and Mandarin. Inclusion of these participants will depend upon the availability of the translators and their ability to accurately translate the measures as approved by the local Institutional Review Board (IRB)

Exclusion Criteria:

• PATIENTS EXCLUSION:

• Have surgery planned within 3 months of approach date. Patients who have previously received surgery are eligible

• Presence of symptomatic brain metastases (if more than one) at time of study consent process. Patients with history of treated brain metastases or small indeterminate lesions (< 1cm) are eligible if they are not symptomatic at the time of study enrollment

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Stage III Lung Cancer AJCC v8

Intervention

Other:
• Best Practice
Receive usual care

Procedure:
• Biospecimen Collection
Undergo blood and stool sample collection

Other:
• Communication Intervention
Receive GA assessment summary and assessment-based recommendations
• Comprehensive Geriatric Assessment
Complete GA
• Electronic Health Record Review
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	City of Hope Medical Center	Duarte	California
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 3-5 non-hematologic toxicities	Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0) for grade 3-5 non-hematologic toxicities. Chi-square test will be used to compare proportion of patients with grade 3-5 non-hematologic toxicity between two arms at 6 months after treatment initiation.	At 6 months from treatment initiation
Secondary	Overall grade 3 to 5 toxicities	Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0) for grade 3-5 toxicities. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicities between two arms at 6 months after treatment initiation.	At 6 months from treatment initiation
Secondary	Patient-reported symptomatic toxicities	Will be assessed by the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events and Patient Reported Outcomes Measurement Information System (PROMIS)-10. Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Function	Will be assessed by activities of daily living/instrumental activities of daily living. T test Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Physical performance -SPPB	Will be assessed by the short physical performance battery (SPPB) which is scored according to instruction, range from 0 to 12), T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Physical performance - 2 minute walking	Will be assessed by 2 minute walking test (meters). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Physical performance - number of falls	Will be assessed by number of falls (count number). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Polypharmacy	Will be assessed by the reduction in medication burden. Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 3 months from treatment initiation
Secondary	Mood - GDS	Will be assessed by the Geriatric Depression Scale (GDS) 5/15 (scored according to guideline).; T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Mood - Anxiety	Will be assessed by PROMIS anxiety (scored according to guideline). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Quality of life	Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scored according to guideline.; T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Treatment completion rates	Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Hospitalizations/emergency department visit rates	Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	At 6 months from treatment initiation
Secondary	Incidence of adverse events from durvalumab	Chi-square test or fisher's exact test will be used to examine the difference between the two arms.	After completion of adjuvant treatment (12 months)