New EORTC studies activated in 2012

EORTC trial 18081

Adjuvant peginterferon alpha-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group

Target Accrual: 1200 patients
Study Coordinator:

Alessandro Testori – Istituto Europeo Di Oncologia, Milano

EORTC trial 90101 – CREATE

Cross-tumoral Phase 2 clinical trial exploring crizotinib (PF-02341066) in patients with advanced tumors induced by causal alterations of ALK and/or MET (“CREATE”)

Target Accrual: 582 patients
Study Coordinator:

Patrick SchoeffskiUniversitair Ziekenhuis Gasthuisberg, Leuven

EORTC trial 55092

Phase IB-II, open label, multicentre feasibility study of Pazopanib in combination with Paclitaxel and Carboplatin in patients with platinum-refractory/resistant ovarian, fallopian tube or peritoneal carcinoma

Target Accrual: 36 patients
Study Coordinator:

Ignace VergoteUniversitair Ziekenhuis Gasthuisberg, Leuven

EORTC trial 90111

Neoadjuvant afatinib based treatment strategies followed by surgery in squamous cell carcinoma of the head and neck: an EORTC NOCI-HNCG window study

Target Accrual: 30 patients
Study Coordinator:
Jean-Pascal Machiels
Cliniques Universitaires St. Luc, Brussels

EORTC trial 65091 – 06093

Empirical versus pre-emptive antifungal therapy in patients with haematological malignancies. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups

Target Accrual: 556 patients
Study Coordinator:

Peter DonnellyRadboud University Nijmegen Medical Centre, Nijmegen

EORTC trial 62092-22092

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with Retroperitoneal sarcomas (RPS)

Target Accrual: 256 patients
Study Coordinator:
Sylvie Bonvalot
Institut Gustave Roussy, Villejuif

EORTC studies soon to be opened (in regulatory process)

EORTC trial 75111

Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH/PHM: an open-label multicentre randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group

Target Accrual: 80 patients
Study Coordinator:
Hans P.M.W. Wildiers
Universitair Ziekenhuis Leuven, Leuven

40CRC – SPECTAcolor

An EORTC prospective screening initiative for the determination of molecular parameters for advanced colorectal cancer

Target Accrual: not applicable
Study Coordinator:
Gunnar Folprecht
Universitaetsklinikum Carl Gustav Carus, Dresden

EORTC trial 40091 – BOS 2

Randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab and FOLFOX plus panitumumab in kras as perioperative treatment in patients with resectable liver metastases from wild type KRAS colorectal cancer

Target Accrual: 360 patients
Study Coordinator:

Stephane BenoistHopital De Bicetre AP-HP, Le Kremlin Bicetre
Bernard NordlingerCHU Ambroise Pare AP-HP, Boulogne-Billancourt

EORTC trial 40085

Treatment of patients with KRAS wild type advanced colorectal cancer with 5-fluorouracil (5-FU) or 5-FU plus an Epidermal Growth Factor Receptor inhibitor (cetuximab) based on a Comprehensive Geriatric Assessment

Target Accrual: 150 patients
Study Coordinator:
Marc Peeters
Universitair Ziekenhuis Antwerpen, Edegem

EORTC trial 40084-22084

A phase III trial evaluating both Erlotinib and Chemoradiation as adjuvant treatment for patients with resected head of pancreas adenocarcinoma

Target Accrual: 950 patients
Study Coordinator:
Jean-Luc Van Laethem
Hospital Universitaire Erasme, Brussels

EORTC trial 26112

An International, Randomized, Double-Blind, Controlled Phase II Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (Irradiance)

Target Accrual: 140 patients
Study Coordinator:
Kirsten Hopkins
University Hospitals Bristol NHS Foundation Trust, Bristol
Michael WellerUniversitätsSpital Zürich, Zurich

EORTC trial 22055 – 08053

Phase III study comparing post-operative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement – LUNG-ART

Target Accrual: 700 patients
Study Coordinator:

Cecile Le PechouxInstitut Gustave Roussy, Villejuif

EORTC trial 21082

Progression free survival (PFS) comparison between suberoylanilide hydroxamic acid (SAHA, Vorinostat TM) in combination with bortezomib (Velcade TM) and SAHA alone in refractory or recurrent advanced CTCL. A randomized study.

Target Accrual: 189 patients
Study Coordinator:
Pablo Luis Ortiz-Romero
Hospital Universitario, Madrid

EORTC trial 20101

Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma (H11), a randomized phase III non-inferiority study of the EORTC Lymphoma Group and the Polish Lymphoma Research Group

Target Accrual: 570 patients
Study Coordinator:

Martin HutchingsRigshospitalet, Copenhagen

John Bean
EORTC, Medical Science Writer

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