Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C259- Malignant neoplasm of pancreas, unspecified Health Condition 3: C20- Malignant neoplasm of rectum Health Condition 4: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Dr k Umamaheswara Rao
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult patients (greater than 18 years) with histologically or cytologically confirmed colorectal cancer, pancreatic cancer, or small cell lung cancer who are scheduled to receive or currently receiving an irinotecan-based chemotherapy regimen (e.g., FOLFIRI, FOLFOXIRI, FOLFIRINOX). 2) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 2. 3) Patients with adequate baseline organ function as per institutional protocol as defined by Absolute neutrophil count (ANC) greater than or equal to 150 per cu. mm Platelet count greater than or equal to 100,000 per cu. mm White blood cell count greater than or equal to 3000 per cu. mm Serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN) and transaminases less than or equal to 2.5 times ULN (less than or equal to 5 times ULN if liver metastases are present) Creatinine clearance greater than or equal to 50 mL per min (calculated by Cockcroft Gault or institutional method) 4) Patients willing and able to provide written informed consent for participation and genetic testing (UGT1A1 genotyping). 5) Patients residing in South India and able to understand study-related instructions in the local language to ensure compliance with follow-up.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women. 2) Patients unwilling or unable to provide written informed consent. 3) Patients with inadequate baseline hematological, hepatic, or renal function as defined in the inclusion criteria. 4) Patients with uncontrolled comorbidities (e.g., unstable cardiac disease, uncontrolled hypertension, uncontrolled diabetes) or active infections that may interfere with study participation or irinotecan administration, in the investigator s judgment. 5) Prior severe hypersensitivity reaction to irinotecan or other components of the planned chemotherapy regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the association between UGT1A1 gene polymorphisms and the safety profile of irinotecan in patients with colorectal, pancreatic, and small cell lung cancers receiving irinotecan-based regimens at SVIMS, South India.Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the frequency distribution of UGT1A1 gene polymorphisms in the study population. 2) To assess the correlation between UGT1A1 polymorphisms and the incidence, severity, frequency, and type of irinotecan-related adverse drug reactions (ADRs). 3) To explore the impact of UGT1A1 polymorphisms on treatment modifications (dose reduction, delay, or discontinuation). 4) To evaluate the role of pharmacogenomic profiling in optimizing irinotecan therapy and improving patient safety. Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Irragam reddy Rahul reddy
Sri venkateswara institute of medical sciences and research- SPMCW
Outcome results
None listed