Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China

April 1, 2025 updated by: Lirong Yang, RenJi Hospital

Correlation of the Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores and Unplanned Hospitalizations in Older Cancer Patients--A Multi-center Prospective Cohort Study

The goal of this observational study is to learn about the impact of chemotherapy-related toxicity on older cancer patients in China. The main question it aims to answer is:

Does the Cancer and Aging Research Group (CARG) chemotherapy toxicity risk score predict chemotherapy-related toxicity in Chinese cancer patients over age 70? Participants over age 70 on systemic chemotherapy will answer questions listed in the CARG chemotherapy toxicity risk tool.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Background:

There's a high burden of cancer in the geriatric population. Because of factors such as declining organ function, older adults with cancer generally have lower tolerability of chemotherapy than younger patients. In cancer patients aged ≥ 70 years, chemotherapy-related toxic effects were associated with reduced quality of life and/or decreased physical functioning or death after 1 year. Identifying of older patients at high risk of experiencing chemotherapy-related adverse events is one of the key components for developing new prevention and intervention strategies to improve treatment outcomes in older adults with cancer. The CARG toxicity score prediction model and calculator established by the Cancer and Aging Research Group (CARG) in 2011 is widely used in many countries and regions around the world and are recommended by several international guidelines. However, data from older adults with cancer in China are scarce. Prospective studies exploring the correlation between the CARG chemotherapy risk score and unplanned hospitalizations are limited.

Study Objectives:

  • To assess the predictive value of the CARG chemotherapy toxicity risk score in older adults with cancer in China
  • To explore the correlation between the CARG scores and the unplanned hospitalizations

Study Method:

This is a multi-center prospective cohort study to collect data from cancer patients aged ≥ 70 years from Renji Hospital and Henan Cancer Hospital. Patients will complete the CARG chemotherapy toxicity risk score questionnaires upon initiating a new chemotherapy regimen. The demographics, tumor characteristics (type of cancer and stage), clinical characteristics (e.g. ECOG performance status, NRS-2002 score, and comorbidities), and cancer treatment (e.g. chemotherapy regimen, line of treatment, combined targeted and/or immunotherapy) will be documented for the baseline evaluation. Toxicity, unplanned hospitalization events, and completion of chemotherapy treatment will be assessed for each visit.

Study Type

Observational

Enrollment (Estimated)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Academic medical centers

Description

Inclusion Criteria:

  • Age≥ 70 years old
  • Confirmed diagnosis of solid tumor (any stage)
  • ECOG-PS score 0-2 points
  • Admission to the hospital for a new chemotherapy regimen (initial or change)
  • Patients need to have the ability to read and write, or communicate in Chinese
  • The patient must have the ability to give informed consent.

Exclusion Criteria:

  • Patients who are on immunotherapy and/or targeted therapy only
  • Patients with hematologic malignancy
  • Patients with severe infections (sepsis, severe respiratory tract infections, severe urinary tract infections, severe abdominal infections, etc.).
  • Patients with severe heart, liver, and kidney dysfunction or failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Grade 3-5 Chemotherapy-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
A grade 3 chemotherapy-related adverse event indicates an event that requires hospitalization. A grade 4 event is life-threatening. A grade 5 event is death.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Unplanned Hospitalization Events
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
The unexpected admission to hospital after the initiation of chemotherapy
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Discontinuation Events
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
The delivered cycles are fewer than the planned cycles.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Dose Reduction Events
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
The dose of at least one chemotherapy drug was reduced by at least 15% compared to standard dose.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Dose Delay Events
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
The administration of at least one cytotoxic drug from a chemotherapy regimen was delayed for at least 7 days.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Dose Missing Events
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
During the cycle, at least one drug from the chemotherapy regimen is not administered.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Events of Reduction in Relative Dose Intensity (RDI)
Time Frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Relative dose intensity (RDI) is the ratio of delivered dose intensity to standard or planned dose intensity. An RDI less than 85% is generally considered to be a clinically significant reduction from standard or planned therapy.
Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Lirong Yang, PharmD, Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Xiaoxia Qiu, MS, Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LY2024-267-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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