ACTRN12609000585224已完成2 期
A randomised phase II trial comparing the effect of Camptothecin-11 (CPT-11), Fluorouracil (5FU) and Folinic Acid versus CPT-11, 5FU and Folinic Acid followed by Oxaliplatin, 5FU and Folinic Acid on objective response rate in patients with metastatic colorectal cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 314
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •INCUSION CRITERIA
- •Histologically confirmed metastatic adeno-carcinoma of the colon or rectum.
- •Measurable metastatic disease (at least one) bidimensionally measurable lesion [according to WHO (World Health Organization) criteria].
- •No potentailly resectable metastasis.
- •Patients should be over 18 years old.
- •WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
- •No prior chemotherapy or only adjuvant chemotherapy ended more than 6 months before randomisation.
- •Adequate renal and liver function creatinine <= 1.5 x upper normal limits, Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) <=5 x upper normal limits).
- •Baseline neutrophil count > 1,500/iL and platelet count > 100,000/iL.
排除标准
- •EXCLUSION CRITERIA
- •Pregnant or lactating patients.
- •Patients with reproductive potential who are not using adequate contraceptive measures.
- •Any prior chemotherapy for advanced disease. Adjuvant treatment ended within 6 months preceding study entry.
- •Central Nervous System (CNS) metastases, bone metastases or serosal effusions as the sole indicate of tumour.
- •Current history of chronic diarrhea.
- •Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
- •Other serious illness (recent history of myocardial infarction, < 6 months).
研究者
相似试验
进行中（未招募）
1 期
CIinical trial to compare the efficacy and safety of chemotherapy plus quizartinib versus chemotherapy plus placebo in patients with acute myeloid leukemia without FLT3 mutatioMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Acute myeloid leukemiaEUCTR2018-002851-14-PTFUNDACIÓN PETHEMA272
进行中（未招募）
1 期
CIinical trial to compare the efficacy and safety of chemotherapy plus quizartinib versus chemotherapy plus placebo in patients with acute myeloid leukemia without FLT3 mutatioMedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864Acute myeloid leukemiaEUCTR2018-002851-14-ESFUNDACIÓN PETHEMA281
尚未招募
2 期
A study to compare efficacy of cabazitaxel versus Docetaxel in recurrent head & neck cancerCTRI/2015/06/005848Tata Memorial Hospital92
招募中
2 期
A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopicJPRN-jRCT1040220153Takeuchi Hiroya90
未知
2 期
A phase II randomized study comparing the efficacy and safety of mFOLFOX6 + panitumumab combination therapy and 5-FU/LV + panitumumab combination therapy in the patients with chemotherapy-naive unresectable advanced recurrent colorectal carcinoma of KRAS wild-type after 6 cycles of combination therapy with mFOLFOX6 + panitumumabJPRN-jRCT1080222617TAKEDA PHARMACEUTICAL COMPANY LTD.164