CARG risk score based chemotherapy in older patients with advanced GI cancers phase III trial
- Conditions
- Health Condition 1: K319- Disease of stomach and duodenum, unspecified
- Registration Number
- CTRI/2022/03/040884
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>Timepoint: 6 years