EORTC studies opened since 12 March 2010

EORTC Trial 30073

Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma.

 Target Accrual: 458 patients

Study Coordinators:

• Axel Bex – The Netherlands Cancer Institute – Antoni Van Leeuwenhoekziekenhuis, Amsterdam
• John B.A.G. Haanen – The Netherlands Cancer Institute – Antoni Van Leeuwenhoekziekenhuis, Amsterdam

Studies 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 Coordinator:

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

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 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

 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

John Bean