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Validation of a tool to predict chemotherapy toxicity in older Indian patients with cancer

A multicentric, double blinded, prospective observational cohort study to validate the CARG score as a predictor of â?¥ grade 3 chemotherapy toxicities in older Indian patients with cancer receiving chemotherapy (CARG-IND)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046865
Enrollment
588
Registered
2022-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C768- Malignant neoplasm of other specified ill-defined sites

Interventions

Intervention1: NIL: NIL

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age >=60 years 2.Diagnosed with solid organ cancer 3.Planned for a new line of chemotherapy. The use of targeted agents and immunotherapy are permissible in combination with chemotherapy.

Exclusion criteria

Exclusion criteria: 1.Patients receiving radical intent concurrent chemoradiotherapy 2.Patients who have received 2 or more prior lines of systemic therapy

Design outcomes

Primary

MeasureTime frame
The difference in the incidence of any grade 3-5 chemotherapy-induced toxicity as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 2 months from the start of therapy and that predicted by the CARG chemotherapy risk scoreTimepoint: 2 months

Secondary

MeasureTime frame
1.Incidence of grade 3 chemotherapy-related toxicities in the cohorts of patients with high, intermediate, and low risk scores on the CARG chemotherapy risk assessment scale 2.Incidence of any grade chemotherapy-induced toxicity as per NCI CTCAE v5.0 3.Number of patients completing the assigned therapy 4.Number of patients requiring dose reduction 5.Number of patients requiring hospitalizations for the management of toxicities 6.Factors predicting for the occurrence of grade 3 chemotherapy toxicity, including age, sex, primary tumor, and the CARG score 7.Correlation of the individual components of the CARG score with grade 3 chemotherapy toxicity 8.Accuracy of the CARG risk score in predicting grade 3 toxicities, as expressed by the sensitivity, specificity, and the positive predictive value Timepoint: 6 Months

Countries

India

Contacts

Public ContactMr Bhavesh P Bandekar

Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)

bhavesh.bandekar1988@gmail.com08779187963

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026