CancerNCT06717178
Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China
An observational study of Cancer and Cancer-related Problem/Condition, run by RenJi Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Cancer-related Problem/Condition
- What is being tested?
- Chemotherapy
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 24 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Academic medical centers
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official 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
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.
Read the 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.
- Conditions
- Cancer, Cancer-related Problem/Condition
- Being tested
- Chemotherapy
- Keywords
- Cancer, Toxicity, Geriatric
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Admission to the hospital for a new chemotherapy regimen (initial or change)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
The delivered cycles are fewer than the planned cycles.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start24 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lirong Yang, RenJi Hospital
- Investigators
- Lirong Yang, PharmD, Principal investigator, Renji Hospital affiliated with Shanghai Jiao Tong University School of MedicineXiaoxia Qiu, MS, Principal investigator, Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717178
- Sponsor's protocol ID
- LY2024-267-B
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06717178
- Acronym / sponsor ID
- LY2024-267-B
- Conditions
- Cancer, Cancer-related Problem/Condition
- Keywords
- Cancer, Toxicity, Geriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Academic medical centers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAdmission to the hospital for a new chemotherapy regimen (initial or change) | Drug | – |
Primary outcome
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.
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided. Anonymized individual participant data including clinical characteristics and outcomes will be made available to other researchers on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lirong Yang, PharmD principal investigator
Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
Xiaoxia Qiu, MS principal investigator
Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer-related Problem/Condition, run by RenJi Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.