Phase
Condition
Esophageal Cancer
Esophageal Disorders
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed esophageal carcinoma
Meets the following criteria:
Resectable, locally advanced disease as determined by the combination of CT scan, endoluminal ultrasound (EUS), PET scan, and a multidisciplinary team discussion
T2, N1-3; T3, any N; or T4a, any N (if technically resectable with curative intent [R0] as decided by a multidisciplinary team discussion)
EUS-guided fine-needle aspiration (FNA) allowed, but determines nodal status only if positive FNA
No T1, any N, M0; or T2, N0, M0; T4a (due to infiltration of the trachea-bronchial tree or organ involvement that cannot be operated on with curative intent [R0] as decided by a multidisciplinary team discussion); T4b; or distant metastasis (M1)
Type I or II disease according to the Siewert classification
Squamous cell carcinoma (including basaloid-squamous cell and adenosquamous carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric junction (from 5 cm below the entrance of the esophagus into the thorax to the gastric cardia)
Patients with obstructive tumors are eligible (obstructive tumors will be considered as locally advanced tumors)
No cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic esophagus
No airway infiltration in case of tumors at or above the tracheal bifurcation
No peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric cardia (i.e., esophagogastric junction carcinoma Siewert type I or II)
PATIENT CHARACTERISTICS:
WHO performance status 0-1
Neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Creatinine clearance > 60 mL/min
Bilirubin ≤ 1.0 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
AST ≤ 1.5 times ULN
INR normal
PTT ≤ 1.0 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study therapy
FEV_1 ≥ 1.5 L OR ≥ 75% of the reference value
Must be compliant and geographically proximal for staging and follow-up
Considered operable (i.e., appropriate organ functions and ability to undergo general anesthesia)
No other malignancies within the past 5 years except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
No severe or uncontrolled cardiovascular disease, including any of the following:
NYHA class III-IV congestive heart failure
Unstable angina pectoris
Myocardial infarction within the past 12 months
Significant arrhythmias
No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, and answering questionnaires
No active uncontrolled infection
No serious underlying medical condition that, in the opinion of the investigator, could impair the ability of the patient to participate in the trial (e.g., uncontrolled diabetes mellitus or active autoimmune disease)
No preexisting peripheral neuropathy > grade 1
No definite contraindications for the use of corticosteroids and antihistamines as premedication
No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy to the chest
At least 30 days since prior treatment in another clinical trial
No concurrent drugs contraindicated for use with the trial drugs
No other concurrent anticancer treatments
No other concurrent experimental drugs or investigational treatments
Study Design
Study Description
Connect with a study center
Landeskrankenhaus
Feldkirch, A-6807
AustriaSite Not Available
Universitätsklinik für Innere Medizin I
Innsbruck, A-6020
AustriaSite Not Available
Krankenhaus Barmherzige Schwestern Linz
Linz, A-4010
AustriaSite Not Available
Krankenhaus der Elisabethinen Linz GmbH
Linz, A-4010
AustriaSite Not Available
Universitätsklinikum der PMU Salzburg
Salzburg, A-5020
AustriaSite Not Available
Klinikum Wels-Grieskirchen GmbH
Wels, A-4600
AustriaSite Not Available
Universitätsklinik für Innere Medizin
Wien, 1090
AustriaSite Not Available
Hôpital Avicenne
Bobigny, 93000
FranceSite Not Available
Centre Hospitalier Général
Béziers, 34525
FranceSite Not Available
Hôtel Dieu Estaing
Clermont Ferrand, 63003
FranceSite Not Available
Centre Georges-François Leclerc
Dijon, 21079
FranceSite Not Available
CHU Le Bocage
Dijon Cedex, 21079
FranceSite Not Available
CHRU de Lille
Lille, 59037
FranceSite Not Available
Centre Bourgogne
Lille, 59000
FranceSite Not Available
Clinique François Chénieux
Limoges, 87000
FranceSite Not Available
CHU la TIMONE
Marseille, 13385
FranceSite Not Available
CH Régional de la Source
Orleans, 45067
FranceSite Not Available
CH Saint Jean
Perpignan Cedex, 66046
FranceSite Not Available
Hôpital Haut Leveque
Pessac Cedex, 33604
FranceSite Not Available
CHU
Rennes Cedex 9, 35033
FranceSite Not Available
CHU de Saint Etienne - Hôpital Nord
St Priest En Jarez, 42277
FranceSite Not Available
Clinique Ste Anne
Strasbourg, 67000
FranceSite Not Available
Hôpital Purpan
Toulouse, 31509
FranceSite Not Available
Charite University Hospital - Campus Virchow Klinikum
Berlin, D-13353
GermanySite Not Available
Universitaetsklinikum Duesseldorf
Duesseldorf, D-40225
GermanySite Not Available
Kliniken Essen - Mitte
Essen, D-45136
GermanySite Not Available
Universitaetsklinikum Freiburg
Freiburg, D-79106
GermanySite Not Available
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
GermanySite Not Available
Klinikum Herford
Herford, D-32049
GermanySite Not Available
Klinikum Ludwigsburg
Ludwigsburg, D-71640
GermanySite Not Available
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, D-35043
GermanySite Not Available
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377
GermanySite Not Available
Staedtisches Klinikum Solingen
Solingen, D-42653
GermanySite Not Available
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
GermanySite Not Available
Universitaetsklinikum Tuebingen
Tuebingen, D-72076
GermanySite Not Available
Szent Laszlo Korhaz
Budapest, 1097
HungarySite Not Available
Hirslanden Klinik Aarau
Aarau, CH-5001
SwitzerlandSite Not Available
Kantonsspital Aarau
Aarau, CH-5001
SwitzerlandSite Not Available
Kantonsspital Baden
Baden, CH-5404
SwitzerlandSite Not Available
St. Claraspital AG
Basel, CH-4016
SwitzerlandSite Not Available
Universitaetsspital-Basel
Basel, CH-4031
SwitzerlandSite Not Available
Inselspital Bern
Bern, CH-3010
SwitzerlandSite Not Available
Kantonsspital Bruderholz
Bruderholz, CH-4101
SwitzerlandSite Not Available
Kantonsspital Graubuenden
Chur, CH-7000
SwitzerlandSite Not Available
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
SwitzerlandSite Not Available
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
SwitzerlandSite Not Available
Kantonsspital Liestal
Liestal, CH-4410
SwitzerlandSite Not Available
Ospedale Civico
Lugano, CH-6903
SwitzerlandSite Not Available
Kantonsspital Olten
Olten, CH-4600
SwitzerlandSite Not Available
Hôpital du Valais (RSV)-CHCVs
Sion, 1951
SwitzerlandSite Not Available
Kantonsspital - St. Gallen
St. Gallen, CH-9007
SwitzerlandSite Not Available
Regionalspital
Thun, 3600
SwitzerlandSite Not Available
Ospedale Italiano
Viganello, CH-6962
SwitzerlandSite Not Available
Kantonsspital Winterthur
Winterthur, CH-8400
SwitzerlandSite Not Available
City Hospital Triemli
Zurich, CH-8063
SwitzerlandSite Not Available
Klinik Hirslanden
Zurich, CH-8032
SwitzerlandSite Not Available
Onkozentrum Klinik im Park
Zurich, 8038
SwitzerlandSite Not Available
UniversitaetsSpital Zuerich
Zurich, CH-8091
SwitzerlandSite Not Available
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