Health Condition 1: C260- Malignant neoplasm of intestinal tract, part unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: NIL: NIL
Control Intervention1: NA: NA
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with the following primary histological and anatomical diagnosis including stage I to IV, Squamous cell carcinoma of the esophagus or GE junction, Adenocarcinoma of the esophagus or GE junction/stomach, Cholangiocarcinoma or gallbladder cancer with adenocarcinoma histology, Pancreatic adenocarcinoma, Colorectal carcinoma 2. Other rarer GI cancers receiving chemotherapy, eg GI NEC, metastatic anal canal SCC etc. 3. Patients who have previously received chemotherapy can be included in the study if they have received chemotherapy for more than 6 months prior to enrolment. 4. Patients can receive a combination of chemotherapy and immunotherapy or targeted therapy. However, patients receiving only targeted therapy or only immunotherapy will not be included in the study. 5. Age more than or equal to 60 years 6. ECOG performance status 0 to 2 7. Patients who can give informed consent for the study. 8. Patients do not have any contraindications to receive chemotherapy 9. Adequate Hematological, hepatic, and renal function parameters as ascertained by the treating physician. There will be no individualized cut off for end-organ dysfunction
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindications against chemotherapy drugs used in the study 2. Clinically significant medical or surgical comorbidities that preclude the use of chemotherapy as per treating physician decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the overall incidence of grade 3-5 TRAEs and its association with CARG-GI score stratification (Low, medium, high)Timepoint: From Baseline to upto four cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the standard CARG score with the newly formed CARG GI score via the AUC method. To assess the dose modifications and treatment delays in all the three risk groups Timepoint: From Baseline to end of systemic chemotherapy | — |
Countries
India
Contacts
Public ContactDr Anant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed