1 / 16

UK Clinical Sarcoma Research

UK Clinical Sarcoma Research. Changes in UK. Appointment of Cancer Tsar Use of NICE to evaluate care pathways and technology/drugs Minimum datasets established Collaboration between funding bodies Creation of NCRN/NCRI and CTAAC NTRAC Clinical Study Groups. Other Resources. NTRAC

kaya
Download Presentation

UK Clinical Sarcoma Research

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. UK Clinical Sarcoma Research

  2. Changes in UK • Appointment of Cancer Tsar • Use of NICE to evaluate care pathways and technology/drugs • Minimum datasets established • Collaboration between funding bodies • Creation of NCRN/NCRI and CTAAC • NTRAC • Clinical Study Groups

  3. Other Resources • NTRAC • National Cancer Tissue Resource • Bioinformatics • Collaborative Database of Clinical Trials in association with U.S. • Competitive tendering for status of Clinical Trials Unit.

  4. National Cancer Research Network National Cancer Research Institute

  5. NCRN • 34 Networks • Set up mid 2001 • £200k per million investment in infrastructure • Target from DOH to double accrual into trials by 2003-4 • baseline April 2000 – April 2001 – approx 3.5%. • Target was 7.5% (approx 15,000) of all incident cases. • Achieved and exceeded.

  6. Portfolio of NCRI Sarcoma Group • Currently only collaborative studies • These include EORTC studies • EURAMOS • Euro-Ewings.

  7. VORTEX • Randomised trial evaluating impact of changes in dose/volume of post-operative radiotherapy on limb function and local recurrence in adult patients with extremity soft tissue sarcoma.

  8. VORTEX

  9. What are the principal research questions to be addressed? How does the margin applied around the surgical bed when planning post-operative radiotherapy for adult extremity soft tissue influence limb function, quality of life and local control?

  10. The proposed trial • This will be a 2-arm trial. • The patients will be stratified according to • tumour size <10cm or no • grade, adequacy of surgical margin • primary or recurrent disease

  11. Treatment A (control) • The first 25 fractions (50Gy) will be given to a volume which gives a 7cm margin to the surgical bed longitudinally and 3cm laterally. • The phase 2 of 14-16Gy in 7-8 fractions will treat a volume giving a 1.5cm margin to the surgical bed cranio-caudally and 2cm laterally.

  12. Treatment B (experimental) • A total of 32-33 fractions of 2Gy should be given once a day for 5 days per week over 6 weeks, totalling 64-66Gy. • The entire treatment shall be given to the volume described as phase 2 in the control arm.

  13. Primary endpoints • Limb function as measured by TESS at 2 years. • Local recurrence at 2 years.

  14. Secondary endpoints • Soft tissue and bone toxicity (RTOG) • Disease free survival • Overall survival • Overall level of disability • Quality of life • Detailed radiotherapy QA

  15. What is the proposed sample size? • 400 patients in 4 years to demonstrate a 15% improvement in TESS score • 80% probability of detecting 10% difference in local control.

  16. Translational research • Blood samples collected for national radiogenomics study from all radiotherapy studies. • Study the association between common genetic variations in relevant candidate genes and normal tissue toxicity. • Ideal data set to study the role of IMRT.

More Related