Historically, some of the strengths of the EORTC have been its ability to conduct cancer clinical trials designed to optimize therapeutic strategies, to address specific niches such as rare tumors, and to apply a multidisciplinary treatment approach. EORTC studies are in practice large international clinical trials. Large international clinical trials provide the correspondingly large sample sizes needed to detect potential benefits of not only new drugs but also of more effective therapies. Trials in rare tumors, too, require such large multi-centered settings in order to meet enrollment criteria, and if one considers the decreased incidence of advanced stage disease as well as the scientific progress that has led to molecular classification of tumors, then the necessity for large multi-centered trials becomes even more apparent.
In light of the nature of EORTC cancer clinical trials, active accrual of patients is an important task, and the combined efforts of the Study Coordinator (SC) and EORTC Headquarters staff are needed to keep a study running smoothly and meeting accrual targets. The EORTC is fortunate in this respect as its SCs are actively involved in their clinical trials and prepared to go above and beyond the call of duty to guarantee the success of a clinical trial.
Consider for example the recent contributions of Dr. Damien Weber MD PhD of the Hôpital Cantonal Universitaire de Genève, SC for the EORTC 22042 – 26042 trial being conducted by the EORTC Radiation Oncology Group in collaboration with the Brain Tumor Group. The EORTC 22042 – 26042 trial fits well into the EORTC repertoire as this academic trial is designed to assess the impact of high-dose radiotherapy (RT) on progression-free survival, treatment tolerance, and post-treatment global cognitive functioning in patients with a diagnosis of either atypical or malignant meningiomas.
Meningiomas are primary brain tumors and have an incidence rate of 6 per 100 000 in the general population. Five to ten percent of these, the non-benign meningiomas, have a more aggressive behavior than benign meningiomas and are associated with early recurrence and tumor progression. Surgical excision alone rarely cures a patient with non-benign meningioma, so adjuvant treatment is necessary. Because non-benign meningiomas are rare tumors, and coupled with the way in which they are histologically classified, data concerning the role of surgery and RT have been difficult to interpret. Timing, dose, and target volume definitions for RT are all controversial.
Indeed, as one would expect in a clinical trial involving a rare disease such as atypical meningioma, patient accrual can pose a significant challenge and can become a real problem if you are not vigilant. In anticipation of poor accrual, this trial was watched closely, and when accrual goals were in danger of not being met, the joint efforts of Dr. Weber and the EORTC Headquarters staff, in this case the Project Manager (PM), Nadège Gosselin, paid off. Dr. Weber personally contacted all the investigators in the study and sent congratulatory letters to investigators upon achieving an accrual. He worked seamlessly with Nadège, reinforced her efforts, and concomitantly forged strong contacts with the investigators. On his own initiative he created a bimonthly 22042-26042 Newsletter, a newsletter which keeps the various study sites informed of progress and issues in the trial. In short, Dr. Weber took charge of the SC position and ensured that the EORTC 22042 – 26042 trial continues to meet accrual goals.
The SC position is demanding, but proactive involvement of the SC with EORTC Headquarters Staff can pay off.
N.B.: The EORTC Investigator’s Handbook 2009 describes procedures that need to be considered when developing clinical trials. This handbook can be viewed here.
John Bean, Nadège Gosselin, and Denis Lacombe