NCT00978549已完成3 期
Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping to control symptoms caused by cancer. It is not yet known whether these treatments are more effective when given with or without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.
PURPOSE: This randomized phase II trial is studying symptom control given together with docetaxel to see how well it works compared with symptom control given without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.
详细描述
OBJECTIVES:
Primary
- To compare overall survival of patients with relapsed adenocarcinoma of the esophagus or stomach after treatment with docetaxel and active symptom control vs active symptom control alone.
Secondary
- To determine the time to documented progression in patients treated with docetaxel.
- To assess response rates to docetaxel in patients treated with docetaxel.
- To determine toxicity of docetaxel in patients treated with docetaxel.
- To assess the quality of life of these patients.
- To evaluate the health economic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the esophagus or stomach, including adenocarcinoma of the esophagogastric junction
- •Advanced disease not amenable to curative treatment
- •Documented progressive disease while receiving or within 6 months of completion of first-line chemotherapy with a platinum- and fluoropyrimidine-based therapy either for advanced disease or as neoadjuvant/perioperative therapy
- •No cerebral or leptomeningeal metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 10 g/dL
- •WBC ≥ 3.0 x 10^9/L
- •ANC ≥ 1.5 x 10^9/L
- •Platelets ≥ 100 x 10^9/L
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Total bilirubin normal
- •ALT ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of treatment
- •No clinically significant peripheral neuropathy (grade 2-4)
- •No prior malignancy except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia
- •No medical or psychiatric condition that would influence the ability of patients to provide informed consent
- •No other serious or uncontrolled illness that, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy with taxanes
- •≤ 1 prior chemotherapy regimen in advanced setting allowed
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Time to documented progression (arm I)
- Response rate (arm I)
- Toxicity (arm I)
- Quality of life as assessed by EORTC QLQ-C30 and -STO22
- Health economic evaluation as assessed by EQ-5D
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)Cancer of the PharynxCancer of the LarynxCancer of the Nasal CavityParanasal Sinus NeoplasmsCancer of the Oral CavityNCT00117572University of Chicago285
进行中（未招募）
3 期
A Study to Test Radium-223 With Docetaxel in Patients With Prostate CancerProstate CancerNCT03574571Memorial Sloan Kettering Cancer Center732
Unknown
2 期
Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid TumorsProstate CancerSolid TumorsBreast CancerNon-small Cell Lung CancerGastric CancerNCT01803503National University Hospital, Singapore80
已完成
3 期
S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone TherapyMetastatic CancerProstate CancerNCT00134056SWOG Cancer Research Network1,038
已完成
3 期
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast CancerBreast CancerNCT00540800National Cancer Institute, Naples139