CTRI/2024/08/072162尚未招募3 期
Perioperative Gemcitabine based chemotherapy versus upfront resection followed by adjuvantcapecitabine with and chemo-radiation in operable Stage III Gall bladder cancers (GBC) –A Randomised, open-label, Two-Arm phase III Prospective Clinical Trial - GB-GeCCOR II
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
- •1.Histologically confirmed adenocarcinoma (FNAC or biopsy) of the
- •gallbladder
- •2.No radiological or clinical evidence of metastatic disease and no
- •evidence of metastatic disease as discovered by on-table evaluation
- •during definitive surgery
- •3.Patients presenting with pT3 or/and pN + disease after simple
- •cholecystectomies who are non-metastatic and still resectable
- •4.The patients who present with upfront cT3 and or cN+ disease and are
- •non-metastatic and resectable
- •5.The patients who present with upfront cT2 and cN+ disease and are
- •non-metastatic and resectable
- •6.Operable disease decided in MDT
- •7.ECOG performance status 0 - 1
- •8.Patient does not have any contraindications to receive chemotherapy
- •9.Adequate hematological, hepatic and renal function parameters -
- •hematological- Hb greater than 80 g/L, ANC greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L.
- •Liver functions- bilirubin lesser than or equal to 2 x upper limit normal (ULN),
- •AST/ALT lesser than or equal to 5 x ULN, S. albumin greater than or equal to 2.8 g/L
- •10.Renal function- Creatinine lesser than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 50 mL/min.
- •11.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 phase of the trial.
排除标准
- •1.Known hypersensitivity or contraindications against gemcitabine,
- •cisplatin, Nab-Paclitaxel or CAPECITABINE or radiation therapy.
- •2.Radiological T1 patients will not be included if radiologists are sure
- •about the cT1 at presentation
- •3.Clinically significant active coronary heart disease, cardiomyopathy,
- •valvular heart disease or congestive heart failure, NYHA III-IV,
- •4.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
- •5.Other severe internal disease or acute infection
- •6.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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