CTRI/2022/03/040884尚未招募3 期
A randomized phase III clinical trial evaluating the non-inferiority of reduced dose chemotherapeutic regimens based on CARG risk scores compared to standard doses in older patients with advanced esophageal, esophagogastric, gastric, and biliary tract cancers - CARGO
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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