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NCT Number: NCT06717178

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

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.

Recruiting

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan Cancer Hospital, Zhengzhou, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Admission to the hospital for a new chemotherapy regimen (initial or change)

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lirong Yang

CONTACT

[email protected]

0086+13122098659

Xiaoxia Qiu

CONTACT

[email protected]

0086+13162463959

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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