CTRI/2019/05/019323尚未招募2 期
A two arm randomized open label Phase II clinical trial to assessthe efficacy of Gemcitabine-cisplatin or Capecitabine and Concurrent chemoradiation in Operated stage II and III GB cancer - GECCOR-GB
试验速览
- 阶段
- 2 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
- •Histologically confirmed adenocarcinoma of the gallbladder post resection
- •-No radiological or clinical evidence of metastatic disease
- •-No metastatic disease as discovered by on-table evaluation during definitive surgery for GBC peritoneal disease, liver metastases etc
- •-R0/R1 resection
- •-ECOG performance status 0 - 1
- •-Patient does not have any contraindications to receive chemotherapy
- •-Adequate hematological, hepatic and renal function parameters
- •-Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment Written patient consent form
- •-Able to read, write and understand either Hindi, English, Marathi, or Bengali.
排除标准
- •-R2 surgical resections
- •-Known hypersensitivity or contraindications against gemcitabine, cisplatin, or capecitabine
- •-Clinically significant active coronary heart disease, cardiomyopathy, valvular heart disease or congestive heart failure, NYHA III-IV
- •-Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
- •Evidence of sensorineural hearing loss more than or equal too moderate degree as per pure tone audiometry
- •-Other severe internal disease or acute infection
- •-Baseline neuropathy NCI CTCAE version 4 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
研究者
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