CTRI/2018/04/013218进行中（未招募）3 期
Adjuvant Chemotherapy or Chemo-radiation in Gall Bladder Cancer: A Phase III Randomized Controlled Study (ACCeleRate trial) - cancer,gall bladder,chemotherapy,radiotherapy,ACCeleRate
试验速览
- 阶段
- 3 期
- 状态
- 进行中（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
- •a.Histologically proven cases of adenocarcinoma of gall bladder
- •b.Patients have undergone radical cholecystectomy by a surgeon with training in gastro-intestinal surgery or a surgical oncologist working in a high-volume center
- •c.Patient has recovered from surgical morbidity
- •d.There is no more than 3 months of time gap between date of radical surgery and start of adjuvant therapy (It is possible to start adjuvant therapy within 3 months of surgery)
- •e.Written consent is obtained
- •f.ECOG Performance status <2
- •g.Age >18 years
- •h.Adequate bone marrow functions reflected as Hemoglobinïâ?¬Â¾ 10gm/dl, TLC ïâ?¬Â¾4,000/cmm(ANCïâ?¬Â¾1,500/cmm), and Platelets ïâ?¬Â¾1,00,000/cmm)
- •i.Serum creatinine ïâ?¬Â¼ 1.8 mg%
- •j.Serum bilirubin ïâ?¬Â¼3 mg%
- •k.Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit
- •l.No prior exposure to oxaliplatin, oxaliplatin, capecitabine or radiation therapy
- •Exclusion criteria
排除标准
- •a.Women of reproductive age group not practicing contraception
- •b.Lactating and pregnant women
- •c.Patients who are on other investigational drugs
- •d.History of previous carcinoma in last 5 yrs.
- •e.Active hepatitis B, C or HIV infection
研究者
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