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S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

2013年9月4日 更新者：Southwest Oncology Group

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.

Secondary

  • Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.

Exploratory Analyses (subject to funding availability)

  • Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine (γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum (XPA) with response and survival of patients treated with this regimen.
  • Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and after treatment with this regimen with survival of these patients.
  • Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.
  • Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy.
  • Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.

研究类型

介入性

注册 (实际的)

98

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Mobile、Alabama、美国、36652-2144
        • Mobile Infirmary Medical Center
    • Alaska
      • Anchorage、Alaska、美国、99508
        • Providence Cancer Center
    • Arkansas
      • Bentonville、Arkansas、美国、72712
        • Highlands Oncology Group - Springdale
    • California
      • Castro Valley、California、美国、94546
        • East Bay Radiation Oncology Center
      • Castro Valley、California、美国、94546
        • Eden Medical Center
      • Castro Valley、California、美国、94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont、California、美国、94538
        • Valley Medical Oncology
      • Los Angeles、California、美国、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland、California、美国、94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland、California、美国、94602
        • Highland General Hospital
      • Oakland、California、美国、94609
        • Larry G Strieff MD Medical Corporation
      • Oakland、California、美国、94609
        • CCOP - Bay Area Tumor Institute
      • Oakland、California、美国、94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland、California、美国、94609
        • Tom K Lee, Incorporated
      • Palm Springs、California、美国、92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton、California、美国、94588
        • Valley Care Medical Center
      • Pleasanton、California、美国、94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Sacramento、California、美国、95817
        • University of California Davis Cancer Center
      • San Pablo、California、美国、94806
        • Doctors Medical Center - San Pablo Campus
    • Colorado
      • Fort Collins、Colorado、美国、80524
        • Poudre Valley Hospital
    • Georgia
      • Gainesville、Georgia、美国、30501
        • Northeast Georgia Medical Center
      • Savannah、Georgia、美国、31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Alton、Illinois、美国、62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Decatur、Illinois、美国、62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Maywood、Illinois、美国、60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Mt. Vernon、Illinois、美国、62864
        • Good Samaritan Regional Health Center
      • Springfield、Illinois、美国、62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove、Indiana、美国、46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond、Indiana、美国、47374
        • Reid Hospital & Health Care Services
    • Kansas
      • Chanute、Kansas、美国、66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City、Kansas、美国、67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado、Kansas、美国、67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kansas City、Kansas、美国、66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman、Kansas、美国、67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal、Kansas、美国、67901
        • Southwest Medical Center
      • Newton、Kansas、美国、67114
        • Cancer Center of Kansas, PA - Newton
      • Olathe、Kansas、美国、66061
        • Olathe Cancer Center
      • Parsons、Kansas、美国、67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt、Kansas、美国、67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina、Kansas、美国、67042
        • Cancer Center of Kansas, PA - Salina
      • Topeka、Kansas、美国、66606
        • Cotton-O'Neil Cancer Center
      • Topeka、Kansas、美国、66606
        • St. Francis Comprehensive Cancer Center
      • Wellington、Kansas、美国、67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita、Kansas、美国、67214
        • Wesley Medical Center
      • Wichita、Kansas、美国、67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita、Kansas、美国、67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita、Kansas、美国、67214
        • CCOP - Wichita
      • Wichita、Kansas、美国、67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita、Kansas、美国、67208
        • Associates in Womens Health, PA - North Review
      • Winfield、Kansas、美国、67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington、Kentucky、美国、40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • Boston University Cancer Research Center
    • Michigan
      • Battle Creek、Michigan、美国、49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids、Michigan、美国、49307
        • Mecosta County Medical Center
      • Detroit、Michigan、美国、48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit、Michigan、美国、48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids、Michigan、美国、49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids、Michigan、美国、49503
        • CCOP - Grand Rapids
      • Grand Rapids、Michigan、美国、49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids、Michigan、美国、49506
        • Metro Health Hospital
      • Holland、Michigan、美国、49423
        • Holland Community Hospital
      • Muskegon、Michigan、美国、49442
        • Hackley Hospital
      • Traverse City、Michigan、美国、49684
        • Munson Medical Center
    • Missouri
      • Cape Girardeau、Missouri、美国、63703
        • Saint Francis Medical Center
      • Gape Girardeau、Missouri、美国、63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Joplin、Missouri、美国、64804
        • St. John's Regional Medical Center
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
      • Saint Louis、Missouri、美国、63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis、Missouri、美国、63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield、Missouri、美国、65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield、Missouri、美国、65804
        • St. John's Regional Health Center
      • Springfield、Missouri、美国、65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
      • Billings、Montana、美国、59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings、Montana、美国、59101
        • Northern Rockies Radiation Oncology Center
      • Billings、Montana、美国、59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings、Montana、美国、59107-7000
        • Billings Clinic - Downtown
      • Bozeman、Montana、美国、59715
        • Bozeman Deaconess Cancer Center
      • Butte、Montana、美国、59701
        • St. James Healthcare Cancer Care
      • Great Falls、Montana、美国、59405
        • Great Falls Clinic - Main Facility
      • Great Falls、Montana、美国、59405-5309
        • Big Sky Oncology
      • Great Falls、Montana、美国、59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Great Falls、Montana、美国、59405
        • Frontier Cancer Center
      • Helena、Montana、美国、59601
        • St. Peter's Hospital
      • Kalispell、Montana、美国、59901
        • Kalispell Regional Medical Center
      • Kalispell、Montana、美国、59901
        • Glacier Oncology, PLLC
      • Kalispell、Montana、美国、59901
        • Kalispell Medical Oncology at KRMC
      • Missoula、Montana、美国、59801
        • Community Medical Center
      • Missoula、Montana、美国、59804
        • Guardian Oncology and Center for Wellness
      • Missoula、Montana、美国、59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula、Montana、美国、59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney、Nebraska、美国、68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Middletown、New York、美国、10940-4199
        • Tucker Center for Cancer Care at Orange Regional Medical Center
    • North Carolina
      • Asheboro、North Carolina、美国、27203-5400
        • Randolph Hospital
      • Asheville、North Carolina、美国、28801
        • Mission Hospitals - Memorial Campus
      • Greensboro、North Carolina、美国、27403-1198
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Reidsville、North Carolina、美国、27320
        • Annie Penn Cancer Center
      • Rutherfordton、North Carolina、美国、28139
        • Rutherford Hospital
    • Ohio
      • Akron、Ohio、美国、44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cincinnati、Ohio、美国、45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Dayton、Ohio、美国、45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton、Ohio、美国、45405
        • Grandview Hospital
      • Dayton、Ohio、美国、45406
        • Good Samaritan Hospital
      • Dayton、Ohio、美国、45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton、Ohio、美国、45415
        • Samaritan North Cancer Care Center
      • Dayton、Ohio、美国、45429
        • CCOP - Dayton
      • Findlay、Ohio、美国、45840
        • Blanchard Valley Medical Associates
      • Franklin、Ohio、美国、45005-1066
        • Middletown Regional Hospital
      • Kettering、Ohio、美国、45429
        • Charles F. Kettering Memorial Hospital
      • Troy、Ohio、美国、45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wilmington、Ohio、美国、45177
        • Clinton Memorial Hospital
      • Xenia、Ohio、美国、45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • AnMed Cancer Center
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
      • Spartanburg、South Carolina、美国、29303
        • CCOP - Upstate Carolina
      • Spartanburg、South Carolina、美国、29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Kingsport、Tennessee、美国、37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Texas
      • Temple、Texas、美国、76508
        • CCOP - Scott and White Hospital
    • Utah
      • American Fork、Utah、美国、84003
        • American Fork Hospital
      • Cedar City、Utah、美国、84720
        • Sandra L. Maxwell Cancer Center
      • Logan、Utah、美国、84321
        • Logan Regional Hospital
      • Murray、Utah、美国、84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden、Utah、美国、84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo、Utah、美国、84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George、Utah、美国、84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City、Utah、美国、84103
        • LDS Hospital
      • Salt Lake City、Utah、美国、84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Virginia
      • Norton、Virginia、美国、24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
    • Washington
      • Bellingham、Washington、美国、98225
        • St. Joseph Cancer Center
      • Bremerton、Washington、美国、98310
        • Olympic Hematology and Oncology
      • Kennewick、Washington、美国、99336
        • Columbia Basin Hematology
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
      • Seattle、Washington、美国、98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle、Washington、美国、98104
        • Fred Hutchinson Cancer Research Center
      • Seattle、Washington、美国、98104
        • Minor and James Medical, PLLC
      • Seattle、Washington、美国、98112
        • Group Health Central Hospital
      • Seattle、Washington、美国、98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle、Washington、美国、98122
        • Polyclinic First Hill
      • Seattle、Washington、美国、98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane、Washington、美国、99202
        • Cancer Care Northwest - Spokane South
      • Spokane、Washington、美国、99204-2967
        • Rockwood Clinic Cancer Treatment Center
      • Wenatchee、Washington、美国、98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan、Wyoming、美国、82801
        • Welch Cancer Center at Sheridan Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction

    • No recurrent disease
    • Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
    • Esophageal disease confined to esophagus and peri-esophageal soft tissue
    • Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

  • Clinical stage II or III disease by CT scan or MRI

    • If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
    • Positron-emission tomography scan is required to confirm stage
  • Measurable or non-measurable disease by x-ray, scanning, or physical examination

  • No celiac axis nodes ≥ 1.5 cm

    • Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
    • Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • White blood cell (WBC) count ≥ 3,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

  • Albumin ≥ 3 g/dL
  • Bilirubin normal

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

  • No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

  • No active pneumonia or inflammatory lung infiltrate

Other

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for esophageal cancer
  • No concurrent intensity-modulated radiotherapy

Surgery

  • No prior surgical resection or attempted surgical resection of esophageal cancer

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Chemo Plus RT, Surgery, Chemo
neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
药品：fluorouracil
Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
其他名称：
  • 5-氟尿嘧啶
药品：oxaliplatin
Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
其他名称：
  • 依沙丁
程序：conventional surgery
The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
辐射：radiation therapy
Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pathological Complete Response
大体时间：10-16 weeks after beginning study treatment
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
10-16 weeks after beginning study treatment

次要结果测量

结果测量
措施说明
大体时间
发生与研究药物相关的 3 至 5 级不良事件的患者人数
大体时间：长达 3 年
仅报告可能、很可能或肯定与研究药物相关的不良事件。
长达 3 年
Overall Survival
大体时间：0-5 years
Measured from time of registration to death, or last contact date
0-5 years
Progression-free Survival
大体时间：0-3 years
measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.
0-3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Southwest Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Lawrence P. Leichman, MD、Desert Regional Medical Center Comprehensive Cancer Center
  • 学习椅：Charles R. Thomas, MD、OHSU Knight Cancer Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年9月1日

初级完成 (实际的)

2009年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2004年7月8日

首先提交符合 QC 标准的

2004年7月9日

首次发布 (估计)

2004年7月12日

研究记录更新

最后更新发布 (估计)

2013年10月11日

上次提交的符合 QC 标准的更新

2013年9月4日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000371963
  • U10CA032102 (美国 NIH 拨款/合同)
  • S0356 (其他标识符：SWOG)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

fluorouracil的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Oman

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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