ACTRN12605000361606进行中(未招募)3 期
Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 1,090 人开始时间: 2005年9月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,090
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated(—)
- 性别
- All
入选标准
- •* Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) or patients with other cancers may be included who have had complete macroscopic resection (R0 or R1 resection) for (i) unusual malignancies of the pancreas, such as acinar cell carcinoma, cystadenocarcinoma etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin. Patients with tumours as in 1(b) will be analysed separately and will be in addition to the recruitment of pancreatic cancer patients.* Histological confirmation of the primary diagnosis.* Histological examination of all resection margins.* No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.* WHO performance status < 2* Fully recovered from the operation and fit to take part in the trial. Life-expectancy of more than 3 months.* Able to attend for administration of the adjuvant therapy.* Able to attend for long-term follow-up.* No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).* No serious medical or psychological condition precluding adjuvant treatment.* Fully informed written consent given.
排除标准
- •* Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
- •* Patients with pancreatic lymphoma.
- •* Macroscopically remaining tumour (R2 resection)
- •* Patients with TNM Stage IVb disease.
- •* Patients younger than 18 years.
- •* Pregnancy.
研究者
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