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Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer

2012年9月20日 更新者：European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Phase II:

  • Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma.
  • Compare the tolerability of these regimens, in terms of acute and late toxicity, in these patients.

Phase III:

  • Compare the disease-free and overall survival of patients treated with these regimens .
  • Compare the quality of life of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Determine the sites of recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG/WHO performance status (0-1 vs 2), participating center, and N stage (N0 vs N1 vs NX). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 8 weeks after prior surgical resection, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses.

Patients then receive additional gemcitabine IV over 30 minutes on days 57, 64, 71, 78, 85, and 92. Beginning on day 57, patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 4 courses.

Quality of life (QOL) is assessed in both arms, according to the following schedules:

  • Arm I: QOL is assessed at baseline; at 3 weeks after the beginning of chemoradiotherapy; after the completion of chemoradiotherapy; every 3 months for 2 years; and then every 6 months for 1 year.
  • Arm II: QOL is assessed at baseline; at 12 weeks; at 16 weeks; every 3 months for 2 years; and then every 6 months for 1 year.

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

PROJECTED ACCRUAL: A total of 538 patients (269 per treatment arm) will be accrued for this study within 3 years.

研究类型

介入性

注册 (实际的)

97

阶段

  • 阶段2
  • 第三阶段

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

  • 以色列
      • Haifa、以色列、31096
        • Rambam Medical Center
  • 德国
      • Berlin、德国、D-10117
        • Charité - Campus Charité Mitte
      • Berlin、德国、D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Duesseldorf、德国、D-40225
        • Universitaetsklinikum Duesseldorf
      • Mainz、德国、D-55101
        • Johannes Gutenberg University
      • Munich、德国、D-80335
        • Munich Oncologic Practice at Elisenhof
  • 比利时
      • Brussels、比利时、1070
        • Hopital Universitaire Erasme
      • Ghent、比利时、B-9000
        • Universitair Ziekenhuis Gent
      • Haine Saint Paul、比利时、7100
        • Hopital De Jolimont
      • Kortrijk、比利时、B-8500
        • Cazk Groeninghe - Campus St-Niklaas
      • Liege、比利时、B-4000
        • CHU Liege - Domaine Universitaire du Sart Tilman
      • Wilrijk、比利时、2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • 法国
      • Abbeville、法国、80101
        • Centre Hospitalier d'Abbeville
      • Annecy、法国、74011 Cedex
        • Centre hospitalier d'Annecy
      • Avignon、法国、84902
        • Hopital Duffaut
      • Avignon、法国、84082
        • Institut Sainte Catherine
      • Beauvais、法国、60021
        • C.H.G. Beauvais
      • Blois、法国、41016
        • Centre Hospitalier de Blois
      • Bordeaux、法国、F-33000
        • Clinique Tivoli
      • Boucher、法国、33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Boulogne Billancourt、法国、F-92104
        • Centre Hospitalier Universitaire Ambroise Pare - Boulogne
      • Boulogne Sur Mer、法国、62200
        • Centre Hospitalier Docteur Duchenne
      • Bourgoin-Jallieu、法国、38300
        • Centre hospitalier Pierre Oudot
      • Caen、法国、14033
        • CHU de Caen
      • Clermont-Ferrand、法国、63003
        • CHR Clermont Ferrand, Hotel Dieu
      • Clichy、法国、92118
        • Hopital Beaujon
      • Colombes Cedex、法国、92701
        • Louis Mourier Hospital
      • Creteil、法国、94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Dax、法国、40107
        • Centre Hospitalier de Dax
      • Dijon、法国、21034
        • Hôpital du Bocage
      • Elbeuf、法国、76503
        • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
      • Grenoble、法国、38043
        • CHU de Grenoble - Hopital de la Tronche
      • La Roche Sur Yon、法国、F-85025
        • Centre Hospitalier departemental
      • Le Mans、法国、F-72000
        • Clinique Victor Hugo
      • Libourne、法国、33500
        • Hôpital Robert Boulin
      • Limoges、法国、87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon、法国、69008
        • Clinique Saint Jean
      • Lyon、法国、69373
        • Centre Léon Bérard
      • Marseille、法国、13385
        • CHU de la Timone
      • Mont-de-Marsan、法国、40000
        • Centre Hospitalier General de Mont de Marsan
      • Montpellier、法国、34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse、法国、68051
        • Centre Hospitalier de Mulhouse
      • Nimes、法国、30029
        • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
      • Paris、法国、75015
        • Hôpital Europeén Georges Pompidou
      • Paris、法国、75018
        • Hopital Bichat - Claude Bernard
      • Paris、法国、75651
        • CHU Pitié-Salpétrière
      • Paris、法国、75674
        • Hôpital Cochin
      • Paris、法国、75970
        • Hôpital Tenon
      • Paris、法国、75571
        • Hopital Saint Antoine
      • Pau、法国、64000
        • C.H.G. De Pau
      • Pierre Benite、法国、69495
        • Centre Hospitalier LYON SUD
      • Poitiers、法国、86021
        • CHU Poitiers
      • Rouen、法国、76031
        • Hôpital Charles Nicolle
      • Strasbourg、法国、67098
        • Hopital Universitaire Hautepierre
      • Strasbourg、法国、67065
        • Centre Paul Strauss
      • Tours、法国、37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy、法国、54511
        • Centre Alexis Vautrin
  • 瑞士
      • Geneva、瑞士、CH-1211
        • Hôpital Cantonal Universitaire de Genève
  • 荷兰
      • Amsterdam、荷兰、1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam

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 pancreatic head adenocarcinoma

  • Prior pancreaticoduodenectomy required

    • Documented histological examination of surgical margins (R0), including retroperitoneal margin
    • Performed within the past 8 weeks
  • Any number of lymph nodes (less than 10 OR 10 or more) allowed
  • No periampullary cancer

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 3,500/mm^3
  • Platelet count greater than 150,000/mm^3
  • Hemoglobin greater than 9.0 g/dL

Hepatic

  • Bilirubin less than 1.5 times normal
  • AST and ALT less than 3.0 times normal

Renal

  • Creatinine less than 1.2 mg/dL

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No other concurrent anticancer agents

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

研究衡量的是什么？

主要结果指标

结果测量
Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III

次要结果测量

结果测量
Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0 and EORTC QLQ PAN-26 every 3 months in years 1-2 and every 6 months thereafter

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

European Organisation for Research and Treatment of Cancer - EORTC

合作者

Federation Francophone de Cancerologie Digestive

调查人员

  • 学习椅：Volker G. Budach, MD, PhD、Charite University, Berlin, Germany
  • 学习椅：Pascal Hammel, MD, PhD、Hopital Beaujon
  • 学习椅：Jean-Luc Van Laethem, MD, PhD、Erasme University Hospital

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

2003年5月1日

初级完成 (实际的)

2007年1月1日

研究注册日期

首次提交

2003年7月8日

首先提交符合 QC 标准的

2003年7月8日

首次发布 (估计)

2003年7月9日

研究记录更新

最后更新发布 (估计)

2012年9月24日

上次提交的符合 QC 标准的更新

2012年9月20日

最后验证

2012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

  • EORTC-40013-22012
  • EORTC-40013
  • EORTC-22012
  • FFCD-0304
  • EU-20540

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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