gms | German Medical Science

Purpose: To guarantee the treatment quality of IF-RT of pts in the HD10 and HD11 trials of the GHSG with 460 participating study centers, a quality assurance program (QAP) was conducted. It was based on a central prospective radiation oncological review of all pts diagnostic imaging and clinical findings. The purpose was to assess the feasibility of such a procedure, its impact on the final definition of disease extension and on pts management.

Materials: Between 1998-2002, 1371 pts were enrolled into the HD10 and 1570 pts into the HD11. All study centers were required to score disease involvement at a total of 34 possible sites on case report forms (CRF) and sent them together with all diagnostic imaging to the RT reference center. Here, the images were reviewed and compared with the CRF. Complete sets of documentation of 89% of pts both in HD10 and HD11 were submitted to the reference center.

Results: The evaluation of the QAP showed that a considerable proportion of involved sites, were not or incorrect recorded on the CRF. For pts in HD10 there was a correction of the disease involvement in 49%, for pts in HD11 in 67%. This resulted in a change of disease stage in 40/1529 pts whose documented disease involvement had to be corrected. 93/1529 pts had to be treated in a different protocol, due to changes of stage and risk factors. Due to the incorrect lymph node documentation the RT treatment volume had to be enlarged in 891/1529 pts and reduced in 82/1529 pts.

Conclusion: A central prospective review of pts data and consecutive prescription of individual RT treatment volume is feasible within large multicenter trials. Such a procedure has a significant impact on the correctness of stage definition, allocation to treatment groups and extension of the IF treatment volume.