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

NCT06717178 | Recruiting

• 1 other identifier: LY2024-267-B
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer; Cancer-related Problem/Condition

Keywords

Cancer; Toxicity; Geriatric

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Grade 3-5 Chemotherapy-Related Adverse Events as Assessed by CTCAE v4.0

  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

  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 Outcomes (5)

• Number of Participants with Treatment Discontinuation Events

  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

  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

  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

  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)

  Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy

Interventions

Chemotherapy DRUG

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Academic medical centers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lirong Yang

CONTACT

0086+13122098659; lirongyang950@163.com

Xiaoxia Qiu

CONTACT

0086+13162463959; chouxiaoxia@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: December 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

CN (2)