An observational study in Cancer and Cancer-related Problem/Condition, sponsored by RenJi Hospital. Completed at 2 sites in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by RenJi Hospital · Observational
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 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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 360 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
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Exclusion Criteria:
Admission to the hospital for a new chemotherapy regimen (initial or change)
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.
Time frame: 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
Time frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Number of Participants with Treatment Discontinuation Events
The delivered cycles are fewer than the planned cycles.
Time frame: 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
The dose of at least one chemotherapy drug was reduced by at least 15% compared to standard dose.
Time frame: 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
The administration of at least one cytotoxic drug from a chemotherapy regimen was delayed for at least 7 days.
Time frame: 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
During the cycle, at least one drug from the chemotherapy regimen is not administered.
Time frame: 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)
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.
Time frame: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Plan to share: Undecided — Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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RenJi Hospital