Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT06139627
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Geriatric Assessment and Management (GAM) for Older Adults With Non-Small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy (GAM-CRT)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-07140 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 23398 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |