Status:
RECRUITING
Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Eligibility:
All Genders
60+ years
Phase:
NA
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 radi...
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, sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 19 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06139627
Start Date
May 21 2024
End Date
July 19 2026
Last Update
July 4 2025
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of Rochester
Rochester, New York, United States, 14642
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210