Health Condition 1: C768- Malignant neoplasm of other specified ill-defined sites
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)