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S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

2012年7月12日 更新者：Southwest Oncology Group

Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.

研究概览

地位

终止

条件

干预/治疗

详细说明

OBJECTIVES:

  • Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.)
  • Assess the frequency and severity of toxicities associated with this regimen.
  • Explore, preliminarily, the association between DNA repair genes (ERCC-1, XRCC1, GST-P1, XPD, XPA, ribonucleotide reductase), target enzymes (thymidylate synthase [TS], dihydropyrimidine dehydrogenase, thymidine phosphorylase [TP]), and angiogenic factors (vascular endothelial growth factor [VEGF], epidermal growth factor [EGF], PD-ECGF, basic fibroblast growth factor, TSP-1 and -2, transforming growth factor [TGF]-β, and IL-8) and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach. (This will not be completed as this study was closed early due to poor accrual.)
  • Explore, preliminarily, the association of haplotypes of candidate genes of TS, TP, ERCC-1, XPD, GST-P1, cyclooxygenase-2, EGF receptor, TGF-β, VEGF, and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients. (This will not be completed as this study was closed early due to poor accrual.)
  • Explore, preliminarily, the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy. (This will not be completed as this study was closed early due to poor accrual.)

OUTLINE: This is a multicenter, pilot study.

  • Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity.
  • Neoadjuvant chemoradiotherapy: Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47, 50-54, 57-61, 64-68, and 71-75 in the absence of disease progression or unacceptable toxicity.
  • Surgery: Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy.

Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

7

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
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Burbank、California、美国、91505
        • Providence Saint Joseph Medical Center - Burbank
      • Los Angeles、California、美国、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Palm Springs、California、美国、92262
        • Desert Regional Medical Center Comprehensive Cancer Center
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Cancer Center at UC Health Sciences Center
      • Denver、Colorado、美国、80220
        • Veterans Affairs Medical Center - Denver
      • Edwards、Colorado、美国、81632
        • Shaw Regional Cancer Center
    • Georgia
      • Savannah、Georgia、美国、31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah、Georgia、美国、31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • 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
      • Salina、Kansas、美国、67401
        • Tammy Walker Cancer Center at Salina Regional Health 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
      • 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
      • 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
      • Great Falls、Montana、美国、59405-5309
        • Big Sky Oncology
      • Great Falls、Montana、美国、59405
        • Sletten Cancer Institute at Benefis Healthcare
      • 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
      • 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
    • New York
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester、New York、美国、14623
        • Interlakes Oncology/Hematology PC
    • North Carolina
      • Goldsboro、North Carolina、美国、27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • 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
      • Kettering、Ohio、美国、45429
        • Charles F. Kettering Memorial Hospital
      • Middletown、Ohio、美国、45044
        • Middletown Regional Hospital
      • Troy、Ohio、美国、45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia、Ohio、美国、45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Texas
      • Dallas、Texas、美国、75230
        • Medical City Dallas Hospital
    • Virginia
      • Danville、Virginia、美国、24541
        • Danville Regional Medical Center
    • 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
      • Mt. Vernon、Washington、美国、98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
      • 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
      • Wenatchee、Washington、美国、98801-2028
        • Wenatchee Valley Medical Center
      • Yakima、Washington、美国、98902
        • North Star Lodge Cancer Center at Yakima Valley 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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:

    • Newly diagnosed disease amenable to curative resection
    • Stage IB-III (T2-4)
  • Measurable or nonmeasurable disease

  • Enlarged lymph nodes outside of radiation fields must have preoperative biopsies

    • No positive lymph nodes outside of radiation fields
  • No distant metastasis
  • No gastroesophageal junction tumors

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • WBC ≥ 3,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal
  • Albumin ≥ 3 g/dL
  • Bilirubin normal
  • No evidence of ischemic heart disease by EKG
  • No coronary artery disease requiring active medical treatment
  • No symptoms of angina
  • No history of myocardial infarction
  • No deep vein thrombosis within the past 12 months
  • No pre-existing peripheral neuropathy
  • No active pneumonia or inflammatory lung infiltrate
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years
  • No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy
  • No prior coronary angioplasty or stenting
  • No concurrent 2-dimensional or intensity-modulated radiotherapy

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：Chemotherapy, Chemoradiation, Surgery

Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43.

Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy
药品：capecitabine
850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.
其他名称：
  • 希罗达 (NSC-712807)
药品：oxaliplatin
130 mg/m2 by 2-hour infusion Days 1 and 22
其他名称：
  • Eloxatin (NSC-266046)
程序：conventional surgery
Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy
其他名称：
  • 胃切除术
辐射：radiation therapy
Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.
其他名称：
  • 转播

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
Pathologic Complete Response
大体时间：17-19 weeks
Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.
17-19 weeks

次要结果测量

结果测量
措施说明
大体时间
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
大体时间：Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.
Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.
Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.

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：Syed A. Ahmad, MD、Barrett Cancer Center

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

2006年5月1日

初级完成 (实际的)

2009年4月1日

研究注册日期

首次提交

2006年6月8日

首先提交符合 QC 标准的

2006年6月8日

首次发布 (估计)

2006年6月12日

研究记录更新

最后更新发布 (估计)

2012年8月17日

上次提交的符合 QC 标准的更新

2012年7月12日

最后验证

2012年7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

  • CDR0000476577
  • U10CA032102 (美国 NIH 拨款/合同)
  • S0425 (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.

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赞助者和合作者

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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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