Recruiting

Geriatric Assessment

Sponsor:

City of Hope Medical Center

Code:

NCT06139627

Conditions

Lung Non-Small Cell Carcinoma

Stage III Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Best Practice

Biospecimen Collection

Communication Intervention

Comprehensive Geriatric Assessment

Electronic Health Record Review

Study Details

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

Study ID

NCT06139627

Start date

May 21, 2024

Status verified date

Jul, 2026

Completion date

Jul 19, 2031

Anticipated

Primary completion date

Jul 19, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (GA intervention)

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.

active comparator: Arm II (usual care)

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.

Interventions

Best Practice

Receive usual care

Biospecimen Collection

Undergo blood and stool sample collection

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

Primary outcome measure

  • Incidence of grade 3-5 non-hematologic toxicities [ Time Frame: At 6 months from treatment initiation ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Arya Amini

626-256-4673Aamini@coh.org

Principal Investigator:

Arya Amini

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carolyn J. Presley

614-293-9869Carolyn.Presley@osumc.edu

Principal Investigator:

Carolyn J. Presley

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-08.