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

NCT06139627 | Recruiting DMC

• 3 other identifiers: 23398NCI-2023-07140P30CA033572
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Overall grade 3 to 5 toxicities

  At 6 months from treatment initiation

• Patient-reported symptomatic toxicities

  At 6 months from treatment initiation

• Function

  At 6 months from treatment initiation

• Physical performance -SPPB

  At 6 months from treatment initiation

• Physical performance - 2 minute walking

  At 6 months from treatment initiation

Study Arms (2)

Arm I (GA intervention)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Communication Intervention; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Survey Administration

Arm II (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Procedure: Biospecimen Collection; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Biospecimen Collection PROCEDURE

Undergo blood and stool sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (GA intervention); Arm II (usual care)

Communication Intervention OTHER

Receive GA assessment summary and assessment-based recommendations

Arm I (GA intervention)

Comprehensive Geriatric Assessment OTHER

Complete GA

Arm I (GA intervention); Arm II (usual care)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (GA intervention); Arm II (usual care)

Survey Administration OTHER

Ancillary studies

Arm I (GA intervention); Arm II (usual care)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

NOT YET RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Geriatric Assessment

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Arya Amini

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: November 18, 2023
• Study Start: May 21, 2024
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (3)