Lung Non-Small Cell CarcinomaNCT06139627
Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy
A study testing Best Practice, Biospecimen Collection and Communication Intervention in people with Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by City of Hope Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8
- What is being tested?
- Best Practice, Biospecimen Collection and Communication Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 May 2024to 19 Jul 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Carolyn J. Presley, 614-293-9869, Carolyn.Presley@osumc.edu
Carolyn J. Presley
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Arya Amini, 626-256-4673 ext. 82247, Aamini@coh.org
Arya Amini
- Not yet recruiting
University of Rochester
Rochester, New York, 14642
Supriya G. Mohile, 1-585-275-2121, Supriya_mohile@urmc.rochester.edu
Supriya G. Mohile
About this study
Official title: Geriatric Assessment and Management (GAM) for Older Adults With Non-Small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy (GAM-CRT)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Being tested
- Best Practice, Biospecimen Collection, Communication Intervention, Comprehensive Geriatric Assessment, Electronic Health Record Review
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and stool sample collection
Communication InterventionOther
Receive GA assessment summary and assessment-based recommendations
Comprehensive Geriatric AssessmentOther
Complete GA
Electronic Health Record ReviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months from treatment initiation
Secondary outcomes (13)
Overall grade 3 to 5 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 toxicities. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicities between two arms at 6 months after treatment initiation.
Measured: At 6 months from treatment initiation
Patient-reported symptomatic toxicities
Will be assessed by the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events and Patient Reported Outcomes Measurement Information System (PROMIS)-10. Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Function
Will be assessed by activities of daily living/instrumental activities of daily living. T test Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Physical performance -SPPB
Will be assessed by the short physical performance battery (SPPB) which is scored according to instruction, range from 0 to 12), T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Physical performance - 2 minute walking
Will be assessed by 2 minute walking test (meters). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Physical performance - number of falls
Will be assessed by number of falls (count number). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Polypharmacy
Will be assessed by the reduction in medication burden. Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 3 months from treatment initiation
Mood - GDS
Will be assessed by the Geriatric Depression Scale (GDS) 5/15 (scored according to guideline).
T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Mood - Anxiety
Will be assessed by PROMIS anxiety (scored according to guideline). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Quality of life
Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scored according to guideline.
T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Treatment completion rates
Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Hospitalizations/emergency department visit rates
Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: At 6 months from treatment initiation
Incidence of adverse events from durvalumab
Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Measured: After completion of adjuvant treatment (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 May 2024
- Primary completion19 Jul 2031 (estimated)
- Study completion19 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arya Amini, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139627
- Sponsor's protocol ID
- 23398
- Other IDs
- NCI-2023-07140, 23398, P30CA033572
- Status last verified
- Jul 2026
- First submitted
- 5 Oct 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No