Overview of the Cancer and Aging Research Group Geriatric Oncology Therapy Optimization

The CARG GOTO program supported by the Rising Tide Foundation for Clinical Cancer Research and City of Hope, aims to address knowledge gaps in cancer treatment for older adults. Led by Dr. William Dale, this initiative involves five coordinated research studies focusing on older patients with cancer who are typically underrepresented in clinical trials. The program seeks to improve treatment decisions by including patient partners and experts in geriatric oncology. The trials, designed with input from older cancer survivors, will use a standardized geriatric assessment to optimize interventions and enhance the relevance and efficacy of treatments for the elderly. This effort is expected to set new standards in geriatric oncology research and improve outcomes for older patients with cancer.

Key Highlights of the Program:

• Collaboration with patient partners and geriatric oncology experts to co-create impactful studies.
• Use of the Practical Geriatric Assessment (PGA) tool to optimize treatments.
• The program aims to set new standards in geriatric oncology research and improve outcomes for older patients.

National Studies

The national studies (GAIN-S, SHINE, DOROTHY, GOCART, GAM-CRT) focus on improving cancer care for older adults through targeted interventions, geriatric assessments, and innovative clinical trials designed to optimize treatment outcomes across the country.

International Studies

The CARG GOTO initiative spans international studies, addressing unique challenges faced by older patients with cancer worldwide with GAIN-S Brazil.

---

GAIN-S

GA-Driven Interventions with Supportive Care: Telemedicine to Increase Goal Concordant Care for Older Adults with Cancer in the Community

ClinicalTrials.gov ID: NCT06022965
PI: William Dale, MD, PhD (City of Hope)
Site Lead Investigator: Tanyanika Phillips, MD, MPH
Patient Partners: Lewis Mustian, Lester Wakefield
Participating Sites: City of Hope (Antelope Valley, CA), City of Hope (Upland, CA), City of Hope (Duarte, CA)

The study will be conducted at two community sites within City of Hope’s (COH)’s comprehensive cancer center network, Upland and Antelope Valley, where patients will be assigned to either validated Cancer and Aging Research Group Geriatric Assessment (CARG GA)-driven interventions with supportive care or standard of care (SOC). Each site will be quantitatively evaluated using the Association of Community Cancer Center (ACCC) Geriatric Oncology Gap Assessment tool before and after the study. Eligible patients (age 65+, diagnosed with stage I-IV cancer, starting a new therapy-chemotherapy, immunotherapy, and/or targeted therapy, able to consent, and speaking English, Spanish, or Chinese) will complete a Geriatric Assessment (GA) upon enrollment and be randomized to either the intervention arm (GAIN-S) or SOC. The GA is a multi-dimensional tool targeting deficits for optimization, with data showing reduced chemotherapy toxicity and better quality of life. The primary objective is to implement GA-driven interventions with supportive care via telemedicine to improve communication, prognostic discussions, goal-concordant care, and cost savings. Secondary objectives include reducing treatment toxicity, comparing patient satisfaction, and assessing patient preferences and changes over time.

*GAIN-S was also launched in Brazil which you can read about HERE.

---

DOROTHY

DOse Reduction Of DoceTaxel-Based CHemotherapY in Vulnerable Older Women with Early-Stage Breast Cancer

ClinicalTrials.gov ID: NCT06042569
National PI: Rachel Freedman, MD (DFCI)
Site Principal Investigators: Nicole Williams, MD (OSU), Joanne Mortimer, MD (COH)
Co-Investigator: William Dale, MD, PhD (COH)
Patient Partners: Beverly Canin, Mary Whitehead
Participating Sites: Dana-Farber Cancer Institute (Boston, MA), Ohio State University (Columbus, OH), City of Hope (Duarte, CA)

This study outlines a noninferiority, randomized controlled trial comparing reduced-dose versus standard-dose docetaxel (T) combined with cyclophosphamide (C) in older patients with early-stage HER2-negative breast cancer. The primary outcome is relative dose intensity (RDI). Patients over 65 (n=174) with stage I-III, HER2-negative breast cancer, who are considered vulnerable (CARG-BC score >6), will be randomized to either 80% (Arm A) or 100% (Arm B) of the standard docetaxel dose for four cycles of TC. Primary objectives include comparing RDI, defined as the ratio of actual to standard dose intensity, and secondary objectives include assessing treatment tolerability, patient- and clinician-reported toxicities, changes in function and health status, and survival rates. Toxicity assessments and quality-of-life evaluations will be conducted throughout treatment and follow-up periods.

---

SHINE

A Phase 2 Study of Bright White Light During Treatment with ADT Combination Therapy in Men with Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth

ClinicalTrials.gov ID: NCT05869682
National PI: Alicia K. Morgans, MD, MPH (DFCI)
Site PIs: William Dale, MD, PhD, Sindhuja Kadambi, MD, (UofR), Michael Goodman, MD (WFU)
Co-Investigators: Anthony D’Amico, MD, PhD (DFCI)
Patient Partners: Richard Gelb, Gary Wallach
Participating Sites: Dana Farber Cancer Institute (Boston, MA), University of Rochester (Rochester, NY), Wake Forest University (Winston Salem, NC), City of Hope (Duarte, CA)

This clinical trial aims to evaluate the quality of life (QOL) outcomes and geriatric assessments in men with metastatic prostate cancer starting androgen deprivation therapy (ADT) combination therapy. Participants will be treated with immediate versus delayed bright white light (BWL) exposure through light therapy glasses over a 12-month period. The primary objective is to assess whether immediate BWL therapy reduces patient-reported fatigue at 3 months compared to delayed BWL therapy, using the FACIT-Fatigue instrument. Secondary objectives include comparing mood (PHQ-9), geriatric assessments (CARG-GA and G8), and overall QOL (FACT-P) between the two treatment arms. Exploratory objectives focus on the longitudinal changes in fatigue, mood, geriatric assessments, and overall QOL.

---

GOCART

Geriatric Assessment Guided Optimization to Accelerate Functional Recovery after Chimeric Antigen Receptor T-cell (CAR-T) Therapy for Patients 60 Years and Older with B-cell Non-Hodgkin Lymphoma or Multiple Myeloma

ClinicalTrials.gov ID: NCT06052826
National PI: Andrew Artz, MD, MS
Site PIs: Ashley Rosko, MD (OSU), Heidi Klepin, MD, MS (WFU)
Co-Investigators: William Dale, MD, PhD
Patient Partners: Chuck O’Shea, John Simmons, MD
Participating Sites: City of Hope (Duarte, CA), Ohio State University (Columbus, OH), Wake Forest University School of Medicine (Winston-Salem, NC)

This trial hypothesizes that a GA-informed multi-disciplinary approach, initiated before and continued after CAR-T therapy, will enhance resilience and mitigate early functional decline, cognitive impairment, and malnutrition in older patients. CAR-T cell therapy for relapsed/refractory (r/r) B-cell malignancies and multiple myeloma (MM) shows high response rates and is revolutionizing cancer treatment, yet its use is limited by significant toxicities such as cytokine release syndrome (CRS) and neurological toxicities (NT), particularly in older patients in combination with the Geriatric assessment (GA), which combines patient-reported and objective measures, can identify health deficits and guide optimization strategies. The primary objective is to evaluate the impact of this intervention on physical function decline at 30 days post-CAR-T infusion. Secondary objectives include assessing the success of tri-modality optimization before lymphodepletion, comparing rates of geriatric syndromes, and evaluating the duration and severity of CAR-T-related neurotoxicity between standard care and GA-intervention groups.

---

GAM-CRT

Geriatric Assessment and Management for Older Adults with Non-Small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

ClinicalTrials.gov ID: NCT06139627
National PIs: Supriya Mohile, MD, MS, Carolyn J Presley MD, MHS
Site PIs: Arya Amini, MD
Co-Investigator: William Dale, MD, PhD
Patient Partners: Ann Pennella
Participating Sites: City of Hope (Duarte, CA), University of Rochester (Rochester, NY), Ohio State University (Columbus, OH)

This randomized clinical trial aims to evaluate the effects of providing the oncology care teams with a geriatric assessment (GA) summary and recommendations for GA-directed interventions on outcomes among older adults with unresectable, stage III non-small cell lung cancer (NSCLC). The primary objective is to demonstrate if providing the GA directed interventions improves treatment related toxicities among older adults. Secondary objectives include evaluating differences between the intervention and usual care groups in overall toxicities, patient-reported symptomatic toxicities, implementation of GA recommendations, GA outcomes (function, physical performance, polypharmacy, mood), quality of life, treatment sequencing and completion, and hospitalization/ED rates over 3 to 6 months. An exploratory aim is to examine microbial diversity and blood components as potential biomarkers for treatment-related toxicity and disease response at baseline and 6 months from treatment initiation.