1. Administrative status
Official date of beginning of the project was August 1st, 2001. This interim report describes the status by October 31st, 2003.

2. Status of the data base
Starting from the initial initiative in late 1999 following the Autumn Meeting of the STBSG Group, up to now 196 cases of radiation induced sarcomas (RIS) have been collected. This is the largest series of RIS collected ever. Single cases are still reported by different members of the STBSG and other institutions. The data base is kept open, however new cases will only be considered if tissue material is available for analysis. Of these, 86 cases have been worked-up clinically in deeper detail than initially asked. Data completeness is appr. 85% and missing data are mainly due to cases treated prior to 1990. Fifteen cases had to be eliminated for not fulfilling the criteria for study entry. At present there is a major backlog of data only from two institutions.

3. Invitation to register patients and data transfer
Initially, only members to the STBSG were asked to recruit patients. As the disease is rather rare, any institution interested in sarcoma treatment or translational research of sarcomas can register patients. For these purposes, the data sheet has been posted to website of the main investigator (www.sarkome.de) and can be downloaded. It will also be posted to the website of the STBSG being under construction.

4. Availability of tissue specimen
As expected, not all institutions registering patients were able to provide tissue specimens. A total of 98 samples are available, twelve of them were received after the first main analysis in November 2002. The lack of european law regulations for tissue exchange or delivery of human tissues from one country to another significantly conflicts this type of research.
5. Status of the working program : Histological processing
The histological examination on the overwhelming majority of tissue specimens has been completed. Further specimens await staining and this will be performed as one sample series.

6. Problems with the processing of tissue specimen
Except of those problems described during the first interim report, no further problems did occur as these could be sorted out with collaborators.

7. The translation of pathohistological findings to clinical data
The first correlation analysis between histology and clinical data has been performed on the subgroup of 86 patients undergoing systemic chemotherapy for their RIS. There was a striking difference in expression of different MDR-related genes between RI-osteosarcoma and RI-soft tissue sarcoma. These data will be reported at CTOS, Barcelona, November 6-8, 2003. Data on clinical aspects (previous treatment, time interval to RIS, grading) and histological findings (osteosarcoma, aspects of angiosarcoma) have been presented during EDDM, Brussels, June 23rd, 2003.
The completing of the clinical data base is nearly achieved and we expect a multivariate analysis to be run by the end of this year. The TLR program as applied for will be completed by the end of 2003. Further tissue analysis will be performed on an institutional basis or with the support of the STBSG.

8. Publication status
A first part of the project will be presented during the Meeting of CTOS at Barcelona next month. The contents are related to the results of systemic chemotherapy in RIS and on the correlation of the expression of multidrug resistant genes with response to treatment. The abstract can be read at www.ctos.org.

November 1, 2003-11-14 Peter Hohenberger, M.D., Ph.D.