NCT00374036已完成3 期
Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.
详细描述
To compare the effectiveness of two different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age = 18 years old
- •patients carrying a adenocarcinoma of the stomach or cardia histologically proven
- •locally advanced tumour which may not be treated surgically or metastatic tumour
- •the patients having a stenosante tumour responsible for a disphagy had to have a tumoral ablation or a prosthesis or a probe of food,
- •measurable lesions according to criteria RECIST (specify measurement by spiral scanner of largest diameter of with less the one lesion of size higher than 1 cm) or appraisable but nonmeasurable (lesions < 1 cm, ascite, pleural effusion...)
- •general state WHO < 2
- •absence of insufficiency cardiac or coronary symptomatic
- •absence of previous chemotherapy other that auxiliary stopped since more than 6 months
- •filled questionnaires QLQ C30 and STO-22
- •PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3
- •creatinin ≤ 110 micromol/l
- •bilirubin ≤ 35 micromol/l
排除标准
- •disphagy or intestinal obstruction incompatible with a treatment per os or by a probe of food
- •pregnant or nursing woman
- •previous of cardiac toxicity to the 5FU or to the anthracyclines
- •radiotherapy less than 3 weeks before inclusion, whatever the site
- •other evolutionary cancer threatening the short-term life
- •metastasis cerebral or méningée known (without obligation to seek it)
- •impossibility of regular follow-up for psychological, social, family or geographical reasons
研究组 & 干预措施
1
Experimental
ECC
干预措施: ECC (Drug)
2
Experimental
FOLFIRI
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Time until therapeutic failure : to make pass TET from 15 weeks with ECC in first line to 20 weeks with FOLFIRI in first line
时间窗: 20 weeks
次要结局
- Time of total survival and survival without progression(3 years)
- The percentage of objective answers in first and second line(1 year)
- Percentage of treated patients in second line(3 years)
- Control time of the disease(3 years)
- The tolerance, the quality of life, duration of hospitalization(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung CancerNon Small Cell Lung CancerNCT01005680Eli Lilly and Company256
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
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or MyelodysplasiaLeukemia, Myelocytic, AcuteNCT00136084St. Jude Children's Research Hospital238
已完成
3 期
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk NeuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRecurrent NeuroblastomaRegional NeuroblastomaStage 4 NeuroblastomaStage 4S NeuroblastomaNCT00567567Children's Oncology Group665
进行中（未招募）
3 期
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell TumorsGerminomaMixed Germ Cell TumorYolk Sac TumorChildhood TeratomaMalignant Germ Cell NeoplasmExtragonadal SeminomaGerm Cell TumorNon-seminomatous Germ Cell TumorSeminomaTeratomaChoriocarcinomaNCT02375204Alliance for Clinical Trials in Oncology420