A phase II single arm prospective study to assess the efficacy of Resveratrol-Copper (R-Cu) in ameliorating chemotherapy related toxicity in patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers. - RC

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Histologically confirmed adenocarcinoma of the gastroesophageal junction or the stomach (any T, any N category, M1), or (any T, any N category, M0), but unresectable disease, with the following specifications
•Radiological evidence of metastatic disease or and unresectable local disease as assessed by surgical oncologist
•-ECOG performance status 0 to 2
•-Patient who can give informed consent for the study
•-Patient does not have any contraindications to receive chemotherapy
•-Adequate Hematological, hepatic and renal function parameters
•-Renal function Creatinine less than or equal to 1.5 ULN, Creatinine clearance more than or equal to40 mL per min.
•-Normal cardiac ejection fraction as assessed by echocardiography
•-Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
•-patient given informed consent form

•Patients with Her2 positive metastatic adenocarcinoma planned for her2 directed therapy in addition to chemotherapy as first line regimen
•-Known hypersensitivity against cisplatin, 5-FU, capecitabine, leucovorin, oxaliplatin or docetaxel
•Known contraindications against 5-FU, leucovorin, capecitabine, oxaliplatin, or docetaxel
•Previous history of treatment with docetaxel, 5 FU, oxaliplatin, or capecitabine
•Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV,
•-Clinically significant valvular defect
•-Past or current history of other malignancies except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•-Known brain metastases
•-Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
•-Other severe internal disease or acute infection
•-Baseline neuropathy > NCI Grade I
•-Chronic inflammatory bowel disease
•-On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
•-Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.

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