Studies opened since 27 May 2010 and in regulatory process

Study Opened since 27 May 2010

EORTC trial 21081

A phase III study of Ienalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy 

Target Accrual: 100 patients

Study Coordinator:

• Martine Bagot – Hôpital Saint-Louis (AP-HP), Paris

Studies to be opened soon (in regulatory process)

EORTC trial 26081 – 22086

Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with Newly Diagnosed Anaplastic Oligodendroglioma or Anaplastic Mixed Glioma with Chromosomal Co-delections of 1p and 19q. 

Target Accrual: 544 patients

Study Coordinators:

• Martin J. Van den Bent – Erasmus University Medical Center, Rotterdam
• Frederic Dhermain – Institut Gustave Roussy, Villejuif
• Wolfgang Wick – Universitaetsklinikum Heidelberg – Kopfklinik, Heidelberg

EORTC trial 26091

Randomized trial assessing the significance of Bevacizumab in recurrent grade II and grade III gliomas 

Target Accrual: 144 patients

Study Coordinators:

• Martin van den Bent – Erasmus University Medical Center, Rotterdam
• Ahmed Idbaih – CHU Pitié-Salpêtrière, Paris

EORTC trial 10085

Clinical and biological characterization of Male Breast Cancer: an international retrospective EORTC, BIG and NABCG intergroup study. 

Target Accrual: 1800 patients

Study Coordinator:

• Fatima Cardoso – Institut Jules Bordet – Brussels

EORTC trial 58081

Translational research – observational study for identification of new possible prognostic factors and future therapeutic targets in children with acute lymphoblastic leukemia (ALL) 

Target Accrual: This trial is a prospective observational – biobanking study.

Study Coordinators:

• Helene Cave, Hôpital Robert Debre (AP-HP), Paris
• Yves Benoit, Universiteit Gent, Gent

EORTC trial 40071

Effectiveness of first line treatment with lapatinib and ECF/X in metastatic gastric cancer according to HER2 and EGFR status: a randomized phase II trial 

Target Accrual: 228 patients

Study Coordinator:

• Arnaud Roth – Hôpital Cantonal Universitaire De Genève, Genève

EORTC trial 22071-24071

Randomized Phase III trial on postoperative chemoradiation in combination with anti EGFR-antibody versus postoperative chemoradiation in head and neck squamous cell carcinomas (HNSCC) with high risk of locoregional recurrence 

Target Accrual: 800 patients for the main study, 150 patients for the pre-study

Study Coordinators:

• Wilfried Budach – Heinrich-Heine Universitaetsklinik Dusseldorf, Duesseldorf
• Johannes Langendijk – University Medical Center Groningen, Groningen
• Carla Van Herpen – Radboud University Nijmegen Medical Center, Nijmegen

EORTC trial 62091

A phase IIb/III multicenter study comparing the efficacy of Trabectedin administered as a 3-hour or 24 hour infusion to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma

Target Accrual: 340 patients

Study Coordinator:

• Binh Bui-Nguyen – Institut Bergonie, Bordeaux

Jennifer Crespo and John Bean