Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Academic medical centers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Chemotherapy
DrugAdmission to the hospital for a new chemotherapy regimen (initial or change)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 chemotherapy2
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 chemotherapySecondary outcomes
1
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 chemotherapy2
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 chemotherapy3
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 chemotherapy4
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 chemotherapySponsors and contacts
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Source ClinicalTrials.gov