NCT00268398已完成3 期
Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX
GERCOR - Multidisciplinary Oncology Cooperative Group32 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2002年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 32
- 主要终点
- disease-free survival
研究概览
简要总结
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.
详细描述
OBJECTIVES:
Primary
- Compare the 2-year disease-free survival rate in patients treated with these regimens.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the objective response rate, postoperative complication rate, and transfusing rate in patients having metastasis surgery,
- Determine the pharmacogenetics of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FOLFOX4
Active Comparator
干预措施: oxaliplatin, folinic acid, fluorouracil (Drug)
FOLFOX7 followed by FOLFIRI
Experimental
干预措施: oxaliplatin, irinotecan, folinic acid, fluorouracil (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2-year
次要结局
- Overall survival(2-year, 3-year, 5-year)
- Tolerability(2-year)
- Quality of life(2-year)
- Pharmacogenetics(2-year)
研究者
研究点 (32)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk MedulloblastomaAnaplastic MedulloblastomaMedulloblastomaSupratentorial Embryonal Tumor, Not Otherwise SpecifiedUntreated Childhood Supratentorial Primitive Neuroectodermal TumorNCT00336024Children's Oncology Group91
已完成
3 期
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial CancerEndometrial AdenocarcinomaEndometrial Adenosquamous CarcinomaEndometrial Clear Cell AdenocarcinomaEndometrial Endometrioid Adenocarcinoma, Variant With Squamous DifferentiationEndometrial Serous AdenocarcinomaStage III Uterine Corpus CancerNCT00006011Gynecologic Oncology Group659
已完成
3 期
Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular RetinoblastomaExtraocular RetinoblastomaNCT00554788Children's Oncology Group60
已完成
2 期
Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic CancerMetastatic Pancreatic CancerNCT00786006Asan Medical Center61
进行中（未招募）
3 期
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic LymphomaAdult T Acute Lymphoblastic LeukemiaAnn Arbor Stage II Adult Lymphoblastic LymphomaAnn Arbor Stage II Childhood Lymphoblastic LymphomaAnn Arbor Stage III Adult Lymphoblastic LymphomaAnn Arbor Stage III Childhood Lymphoblastic LymphomaAnn Arbor Stage IV Adult Lymphoblastic LymphomaAnn Arbor Stage IV Childhood Lymphoblastic LymphomaChildhood T Acute Lymphoblastic LeukemiaNCT02112916National Cancer Institute (NCI)847