- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00064207
Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Berlin, 독일, D-10117
- Charité - Campus Charité Mitte
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Berlin, 독일, D-13122
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
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Duesseldorf, 독일, D-40225
- Universitaetsklinikum Duesseldorf
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Mainz, 독일, D-55101
- Johannes Gutenberg University
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Munich, 독일, D-80335
- Munich Oncologic Practice at Elisenhof
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Brussels, 벨기에, 1070
- Hopital Universitaire Erasme
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Ghent, 벨기에, B-9000
- Universitair Ziekenhuis Gent
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Haine Saint Paul, 벨기에, 7100
- Hôpital de Jolimont
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Kortrijk, 벨기에, B-8500
- Cazk Groeninghe - Campus St-Niklaas
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Liege, 벨기에, B-4000
- CHU Liege - Domaine Universitaire du Sart Tilman
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Wilrijk, 벨기에, 2610
- Algemeen Ziekenhuis Sint-Augustinus
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Geneva, 스위스, CH-1211
- Hôpital Cantonal Universitaire de Genève
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Haifa, 이스라엘, 31096
- Rambam Medical Center
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Abbeville, 프랑스, 80101
- Centre Hospitalier d'Abbeville
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Annecy, 프랑스, 74011 Cedex
- Centre Hospitalier d'Annecy
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Avignon, 프랑스, 84902
- Hopital Duffaut
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Avignon, 프랑스, 84082
- Institut Sainte Catherine
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Beauvais, 프랑스, 60021
- C.H.G. Beauvais
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Blois, 프랑스, 41016
- Centre Hospitalier de Blois
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Bordeaux, 프랑스, F-33000
- Clinique Tivoli
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Boucher, 프랑스, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Boulogne Billancourt, 프랑스, F-92104
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne
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Boulogne Sur Mer, 프랑스, 62200
- Centre Hospitalier Docteur Duchenne
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Bourgoin-Jallieu, 프랑스, 38300
- Centre hospitalier Pierre Oudot
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Caen, 프랑스, 14033
- CHU de Caen
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Clermont-Ferrand, 프랑스, 63003
- CHR Clermont Ferrand, Hotel Dieu
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Clichy, 프랑스, 92118
- Hôpital Beaujon
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Colombes Cedex, 프랑스, 92701
- Louis Mourier Hospital
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Creteil, 프랑스, 94010
- Centre Hospitalier Universitaire Henri Mondor
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Dax, 프랑스, 40107
- Centre Hospitalier de Dax
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Dijon, 프랑스, 21034
- Hopital Du Bocage
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Elbeuf, 프랑스, 76503
- Centre Hospitalier Intercommunal St. Aubin les Elbeuf
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Grenoble, 프랑스, 38043
- CHU de Grenoble - Hopital de la Tronche
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La Roche Sur Yon, 프랑스, F-85025
- Centre Hospitalier departemental
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Le Mans, 프랑스, F-72000
- Clinique Victor Hugo
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Libourne, 프랑스, 33500
- Hôpital Robert Boulin
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Limoges, 프랑스, 87042
- Centre Hospital Regional Universitaire de Limoges
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Lyon, 프랑스, 69008
- Clinique Saint Jean
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Lyon, 프랑스, 69373
- Centre Leon Berard
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Marseille, 프랑스, 13385
- CHU de la Timone
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Mont-de-Marsan, 프랑스, 40000
- Centre Hospitalier General de Mont de Marsan
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Montpellier, 프랑스, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Mulhouse, 프랑스, 68051
- Centre Hospitalier de Mulhouse
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Nimes, 프랑스, 30029
- C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
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Paris, 프랑스, 75015
- Hôpital européen Georges Pompidou
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Paris, 프랑스, 75018
- Hôpital Bichat - Claude Bernard
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Paris, 프랑스, 75651
- CHU Pitié-Salpêtrière
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Paris, 프랑스, 75674
- Hôpital Cochin
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Paris, 프랑스, 75970
- Hopital Tenon
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Paris, 프랑스, 75571
- Hôpital Saint Antoine
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Pau, 프랑스, 64000
- C.H.G. De Pau
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Pierre Benite, 프랑스, 69495
- Centre Hospitalier Lyon Sud
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Poitiers, 프랑스, 86021
- CHU Poitiers
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Rouen, 프랑스, 76031
- Hopital Charles Nicolle
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Strasbourg, 프랑스, 67098
- Hopital Universitaire Hautepierre
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Strasbourg, 프랑스, 67065
- Centre Paul Strauss
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Tours, 프랑스, 37044
- Centre Hospitalier Universitaire Bretonneau de Tours
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Vandoeuvre-les-Nancy, 프랑스, 54511
- Centre Alexis Vautrin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
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Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
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Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
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Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III
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2차 결과 측정
결과 측정 |
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Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
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Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
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Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter
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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
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공동 작업자 및 조사자
수사관
- 연구 의자: Volker G. Budach, MD, PhD, Charite University, Berlin, Germany
- 연구 의자: Pascal Hammel, MD, PhD, Hôpital Beaujon
- 연구 의자: Jean-Luc Van Laethem, MD, PhD, Erasme University Hospital
간행물 및 유용한 링크
일반 간행물
- Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13.
- Van Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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