Health Condition 1: K319- Disease of stomach and duodenum, unspecified
Conditions
Interventions
Intervention1:
Arm B (CARG modified doses) - Chemotherapy doses based on CARG risk score (detailed below)
: Dosing schedule in Intermediate risk 80 % Advanced esophageal or GE junction SCC Treatment
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients with advanced or metastatic disease with the following primary histological and anatomical diagnosis Squamous cell carcinoma of the esophagus or GE junction Adenocarcinoma of the esophagus or GE junction or stomach Cholangiocarcinoma or gallbladder cancer with adenocarcinoma histology Patients who have previously received chemotherapy can be included in the study if they have received chemotherapy more than 1 year prior to randomization. Age more than or equal to 65 years 60 to 65 years with a G8 score of more than or equal to 14 ECOG performance status 0 to 2 Patients who can give informed consent for the study. Patients does not have any contraindications to receive chemotherapy, Hematological hepatic and renal function parameters satisfying the parameters mentioned below Hematological Hb more than 80 g per L ANC more than or equal 1.5 x 109 per L platelets more than or equal 100 x 109 per L. Liver functions bilirubin more than or equal 2 x upper limit normal (ULN) AST or ALT more than or equal 5 x ULN albuminmore than or equal 2.5 g per L Renal function Creatinine clearance more than or equal 30 mL per min. No major surgery within the last 4 weeks excepting palliative surgeries like colostomy GJ biliary drainage etc. Baseline age related senile auditory dysfunction allowed even with cisplatin Arthritis or arthralgia related mobility restricted patients allowed if fit for chemotherapy and not interfering with the standard of care dose planning Written patient consent form
Exclusion criteria
Exclusion criteria: Known hypersensitivity or contraindications against chemotherapy drugs used in the study Clinically significant active coronary heart disease cardiomyopathy or congestive heart failure NYHA II to IV Clinically significant valvular defect Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy Uncontrolled medical comorbidities e.g. Diabetes mellitus hypertension etc. Baseline neuropathy more than NCI Grade I. Unhealed surgical wounds Severe hemorrhage On treatment participation in another clinical study in the period 30 days prior to inclusion and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) will be defined as the time from randomization to the time of death, lost to follow-up or last observation, (whichever is earlier). Sample size calculations will be based on the non-inferiority of the OS as an endpoint.Timepoint: 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate whether dose reduced chemotherapy when compared to full-dose chemotherapy leads to Significantly improved Quality of Life (QOL) Improved percentage of patients with good Overall Treatment Utility (OTU) at 2 to 3 months while on treatment with reduced doses as compared to 100% doses.Reduced incidence of grade 3 to 5 treatment-related side effects Differences in Progression Free Survival Timepoint: 6 years | — |
Countries
India
Contacts
Public ContactDr Anant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed