Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
2018年3月2日 更新者：Alliance for Clinical Trials in Oncology
Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes.
Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells.
Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To assess and compare the pathologic complete response (PCR) rate of patients in Arm A receiving the sequence docetaxel, oxaliplatin, and capecitabine (DOC) followed by 5-fluorouracil (5-FU), oxaliplatin, and radiation therapy (RT) with patients in Arm B receiving only 5-FU, oxaliplatin and RT in patients with potentially resectable adenocarcinoma (ACA) of the esophagus, gastroesophageal junction (GEJ), or gastric cardia.
SECONDARY OBJECTIVES:
I. To assess the adverse event (AE) profile and safety of the proposed treatment in this population.
II. To assess and compare the overall survival (OS) between treatment arms. III. To assess and compare the disease-free survival between treatment arms. IV. To assess and compare the clinical tumor response rate of the proposed regiments when administered before surgery between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive fluorouracil* IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery.
ARM II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery as in Arm I.
- NOTE: * Fluorouracil continuous IV infusion begins within 24 hours of radiotherapy and ends within 24 hours of radiotherapy completion.
- NOTE: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of docetaxel, oxaliplatin, and capecitabine.
After completion of study treatment, patients are followed up every 3 months for 2 years.
研究类型
介入性
注册 (实际的)
73
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
-
-
Arizona
-
Scottsdale、Arizona、美国、85259-5499
- Mayo Clinic Scottsdale
-
-
Colorado
-
Fort Collins、Colorado、美国、80524
- Poudre Valley Hospital
-
Fort Collins、Colorado、美国、80528
- Front Range Cancer Specialists
-
-
Connecticut
-
Hartford、Connecticut、美国、06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Florida
-
Jacksonville、Florida、美国、32224
- Mayo Clinic - Jacksonville
-
-
Idaho
-
Boise、Idaho、美国、83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
-
-
Illinois
-
Bloomington、Illinois、美国、61701
- Illinois CancerCare - Bloomington
-
Bloomington、Illinois、美国、61701
- St. Joseph Medical Center
-
Canton、Illinois、美国、61520
- Illinois CancerCare - Canton
-
Canton、Illinois、美国、61520
- Graham Hospital
-
Carthage、Illinois、美国、62321
- Illinois CancerCare - Carthage
-
Eureka、Illinois、美国、61530
- Illinois CancerCare - Eureka
-
Eureka、Illinois、美国、61530
- Eureka Community Hospital
-
Galesburg、Illinois、美国、61401
- Illinois CancerCare - Galesburg
-
Galesburg、Illinois、美国、61401
- Galesburg Clinic, PC
-
Havana、Illinois、美国、62644
- Mason District Hospital
-
Havana、Illinois、美国、62644
- Illinois CancerCare - Havana
-
Kewanee、Illinois、美国、61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb、Illinois、美国、61455
- Illinois CancerCare - Macomb
-
Macomb、Illinois、美国、61455
- Mcdonough District Hospital
-
Moline、Illinois、美国、61265
-
Moline、Illinois、美国、61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth、Illinois、美国、61462
- Illinois CancerCare - Monmouth
-
Monmouth、Illinois、美国、61462
- OSF Holy Family Medical Center
-
Normal、Illinois、美国、61761
- Bromenn Regional Medical Center
-
Normal、Illinois、美国、61761
- Community Cancer Center
-
Normal、Illinois、美国、61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa、Illinois、美国、61350
- Community Hospital of Ottawa
-
Ottawa、Illinois、美国、61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin、Illinois、美国、61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria、Illinois、美国、61636
- Methodist Medical Center of Illinois
-
Peoria、Illinois、美国、61637
- OSF St. Francis Medical Center
-
Peoria、Illinois、美国、61615
- CCOP - Illinois Oncology Research Association
-
Peoria、Illinois、美国、61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru、Illinois、美国、61354
- Illinois CancerCare - Peru
-
Peru、Illinois、美国、61354
- Illinois Valley Community Hospital
-
Princeton、Illinois、美国、61356
- Perry Memorial Hospital
-
Princeton、Illinois、美国、61356
- Illinois CancerCare - Princeton
-
-
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
-
-
Iowa
-
Bettendorf、Iowa、美国、52722
-
Clive、Iowa、美国、50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Clive、Iowa、美国、50325
- Mercy Cancer Center - West Lakes
-
Des Moines、Iowa、美国、50309
- CCOP - Iowa Oncology Research Association
-
Des Moines、Iowa、美国、50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines、Iowa、美国、50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines、Iowa、美国、50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines、Iowa、美国、50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines、Iowa、美国、50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City、Iowa、美国、51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City、Iowa、美国、51102
- Mercy Medical Center - Sioux City
-
Sioux City、Iowa、美国、51104
- St. Luke's Regional Medical Center
-
West Des Moines、Iowa、美国、50266-7700
- Methodist West Hospital
-
-
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
-
Fort Scott、Kansas、美国、66701
- Cancer Center of Kansas - Fort Scott
-
Independence、Kansas、美国、67301
- Cancer Center of Kansas-Independence
-
Kingman、Kansas、美国、67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence、Kansas、美国、66044
- Lawrence Memorial Hospital
-
Liberal、Kansas、美国、67901
- Cancer Center of Kansas, PA - Liberal
-
Newton、Kansas、美国、67114
- Cancer Center of Kansas, PA - Newton
-
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、67401
- Cancer Center of Kansas, PA - Salina
-
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
-
-
Michigan
-
Ann Arbor、Michigan、美国、48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor、Michigan、美国、48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek、Michigan、美国、49017
- Battle Creek Health System Cancer Care Center
-
Dearborn、Michigan、美国、48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba、Michigan、美国、49431
- Green Bay Oncology, Limited - Escanaba
-
Flint、Michigan、美国、48503
- Hurley Medical Center
-
Flint、Michigan、美国、48503
- Genesys Hurley 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
-
Grosse Pointe Woods、Michigan、美国、48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain、Michigan、美国、49801
- Dickinson County Healthcare System
-
Jackson、Michigan、美国、49201
- Foote Memorial Hospital
-
Lansing、Michigan、美国、48912-1811
- Sparrow Regional Cancer Center
-
Livonia、Michigan、美国、48154
- St. Mary Mercy Hospital
-
Muskegon、Michigan、美国、49443
- Mercy General Health Partners
-
Pontiac、Michigan、美国、48341-2985
- St. Joseph Mercy Oakland
-
Port Huron、Michigan、美国、48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Reed City、Michigan、美国、49677
- Spectrum Health Reed City Hospital
-
Saginaw、Michigan、美国、48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Traverse City、Michigan、美国、49684
- Munson Medical Center
-
Warren、Michigan、美国、48093
- St. John Macomb Hospital
-
-
Minnesota
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Burnsville、Minnesota、美国、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、美国、55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth、Minnesota、美国、55805
- CCOP - Duluth
-
Duluth、Minnesota、美国、55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth、Minnesota、美国、55805
- Miller - Dwan Medical Center
-
Edina、Minnesota、美国、55435
- Fairview Southdale Hospital
-
Fridley、Minnesota、美国、55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson、Minnesota、美国、55350
- Hutchinson Area Health Care
-
Maplewood、Minnesota、美国、55109
- HealthEast Cancer Care at St. John's Hospital
-
Maplewood、Minnesota、美国、55109
- Minnesota Oncology - Maplewood
-
Minneapolis、Minnesota、美国、55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis、Minnesota、美国、55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale、Minnesota、美国、55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
-
Saint Louis Park、Minnesota、美国、55416
- CCOP - Metro-Minnesota
-
Saint Louis Park、Minnesota、美国、55416
- Park Nicollet Cancer Center
-
Saint Paul、Minnesota、美国、55102
- United Hospital
-
Saint Paul、Minnesota、美国、55101
- Regions Hospital Cancer Care Center
-
Shakopee、Minnesota、美国、55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Stillwater、Minnesota、美国、55082
- Lakeview Hospital
-
Waconia、Minnesota、美国、55387
- Ridgeview Medical Center
-
Willmar、Minnesota、美国、56201
- Willmar Cancer Center at Rice Memorial Hospital
-
Woodbury、Minnesota、美国、55125
- Minnesota Oncology - Woodbury
-
-
Missouri
-
Bolivar、Missouri、美国、65613
- Central Care Cancer Center at Carrie J. Babb Cancer Center
-
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、59107-7000
- Billings Clinic - Downtown
-
Billings、Montana、美国、59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
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
- Sletten Cancer Institute at Benefis Healthcare
-
Havre、Montana、美国、59501
- Northern Montana Hospital
-
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、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
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87131-5636
- University of New Mexico Cancer Center
-
-
North Carolina
-
Rutherfordton、North Carolina、美国、28139
- Rutherford Hospital
-
-
North Dakota
-
Fargo、North Dakota、美国、58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
Grand Forks、North Dakota、美国、58201
- Altru Cancer Center at Altru Hospital
-
-
Ohio
-
Chillicothe、Ohio、美国、45601
- Adena Regional Medical Center
-
Columbus、Ohio、美国、43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus、Ohio、美国、43222
- Mount Carmel Health - West Hospital
-
Columbus、Ohio、美国、43215
- CCOP - Columbus
-
Columbus、Ohio、美国、43215
- Grant Medical Center Cancer Care
-
Columbus、Ohio、美国、43228
- Doctors Hospital at Ohio Health
-
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、45420
- CCOP - Dayton
-
Delaware、Ohio、美国、43015
- Grady Memorial Hospital
-
Findlay、Ohio、美国、45840
- Blanchard Valley Medical Associates
-
Franklin、Ohio、美国、45005-1066
- Middletown Regional Hospital
-
Greenville、Ohio、美国、45331
- Wayne Hospital
-
Kettering、Ohio、美国、45429
- Charles F. Kettering Memorial Hospital
-
Lancaster、Ohio、美国、43130
- Fairfield Medical Center
-
Marietta、Ohio、美国、45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Mount Vernon、Ohio、美国、43050
- Knox Community Hospital
-
Newark、Ohio、美国、43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Springfield、Ohio、美国、45505
- Community Hospital of Springfield and Clark County
-
Troy、Ohio、美国、45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Westerville、Ohio、美国、43081
- Mount Carmel St. Ann's Cancer Center
-
Xenia、Ohio、美国、45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
Zanesville、Ohio、美国、43701
- Genesis - Good Samaritan Hospital
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton、Pennsylvania、美国、18201
- Geisinger Hazleton Cancer Center
-
State College、Pennsylvania、美国、16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre、Pennsylvania、美国、18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson、South Carolina、美国、29621
- AnMed Cancer Center
-
Greenville、South Carolina、美国、29601
- Bon Secours St. Francis Health System
-
Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
-
Spartanburg、South Carolina、美国、29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
-
Sioux Falls、South Dakota、美国、57105
- Avera Cancer Institute
-
-
Wisconsin
-
Eau Claire、Wisconsin、美国、54703-1510
- Midelfort Clinic - Luther
-
Eau Claire、Wisconsin、美国、54703
- Luther Midlelfort Hospital
-
Green Bay、Wisconsin、美国、54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、美国、54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay、Wisconsin、美国、54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay、Wisconsin、美国、54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc、Wisconsin、美国、54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette、Wisconsin、美国、54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls、Wisconsin、美国、54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sheboygan、Wisconsin、美国、53081
- St. Nicholas Hospital
-
Sturgeon Bay、Wisconsin、美国、54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Sturgeon Bay、Wisconsin、美国、54235-1495
- Door County Cancer Center at Door County Memorial Hospital
-
-
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
Inclusion Criteria
- Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia
- Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that are potentially resectable are also eligible
- Nodal involvement: patients with involvement of celiac nodes, (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction; patients with supraclavicular node involvement are eligible with upper thoracic esophagus primary lesions
- Capable of swallowing pills
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500
- Peripheral platelet count >= 100,000
- Hemoglobin >= 9.0 g/dL
- Total bilirubin =< 1.5 x upper normal limit (UNL)
- Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x UNL
- Creatinine =< 1.5 x UNL
- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Provide informed written consent
- Willingness to return to NCCTG enrolling institution for follow-up
- Patient willing to provide mandatory tissue and blood samples for research purposes
- Patient willing to allow use of FDG PET/CT scans for mandatory research purposes
Exclusion Criteria
- Evidence of distant metastases
- Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic or GE junction
- T1N0M0 or T2N0M0 tumor stage
Any of the following
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans)
- Receiving current treatment or prior treatment for this malignancy
- Other active malignancy 5 years prior to registration, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer
- Prior radiation to > 30% of the marrow cavity
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：随机化
- 介入模型：并行分配
- 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：Arm I (combination chemotherapy, radiation therapy, surgery)
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1.
Patients also receive capecitabine PO BID on days 1-14.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of the second course, patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery.
|
鉴于IV
鉴于IV
给定采购订单
进行手术
接受放射治疗
鉴于IV
|
|
有源比较器：Arm II (oxaliplatin, fluorouracil, radiation, and surgery)
Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy and then surgery as in Arm I.
|
鉴于IV
鉴于IV
进行手术
接受放射治疗
|
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 |
|---|---|---|
|
Percentage of Participants With Pathologic Complete Response (PCR)
大体时间：Up to 2 years
|
Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen.
All lymph nodes should be free of tumor to document a PCR.
If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.
|
Up to 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Up to 2 years
|
Overall survival was defined as the time from randomization to the time of death from any cause.
Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up.
|
Up to 2 years
|
|
Disease-free Survival
大体时间：Up to 2 years
|
Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first.
|
Up to 2 years
|
|
Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event
大体时间：Up to 2 years
|
Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
|
Up to 2 years
|
|
Percentage of Participants With Overall Clinical Tumor Response (CR or PR)
大体时间：Up to 2 years
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Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I).>
CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters.
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Up to 2 years
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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。
出版物和有用的链接
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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
2010年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2009年7月10日
首先提交符合 QC 标准的
2009年7月10日
首次发布 (估计)
2009年7月13日
研究记录更新
最后更新发布 (实际的)
2018年3月29日
上次提交的符合 QC 标准的更新
2018年3月2日
最后验证
2018年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCCTG-N0849
- NCI-2011-01930 (注册表标识符：CTRP (Clinical Trials Reporting System))
- CDR0000646724 (注册表标识符：PDQ (Physician Data Query))
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.