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NCT06139627Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
5 Oct 2023
Start date
21 May 2024
Primary completion date
19 Jul 2031
Lead sponsor
City of Hope Medical Center
Diseases
Lung cancer
NCT number
NCT06139627

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 21 May 2024 to the primary completion date, 19 Jul 2031
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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

Other

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

Who the study is looking for

  • 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)

Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.