Bone Planning Meeting
Future Clinical Trials for Adjuvant Treatment of Osteosarcoma – Prioritising the Questions
With the EURAMOS-1 trial already having recruited more than two-thirds of its patients and with less than 1 year left until the end of patient recruitment, the EURAMOS collaborators are keen to develop strategies on how to continue performing successful multinational trials for patients with osteosarcoma. This may only be accomplished together with other investigators and groups who are facing similar challenges as well as with trial support networks.To this end, a two-day international conference was held in London, UK on the 15th and 16th March 2010 to reflect on recent considerations, review pertinent questions and consider how best to work to address outstanding clinical questions.
Around fifty clinicians, statisticians and trialists participated in the meeting, representing leading osteosarcoma research groups from all over the world including ASSG, COG, COSS, EOI, EORTC, EURAMOS, GEIS, ISG, JCOG, SARC, SFCE and SSG.
List of Attendees
Concept Sheets for Potential New Studies
Gallery
AGENDA
| Future Clinical Trials for Adjuvant Treatment of Osteosarcoma – Prioritising the Questions Wellcome Collection, London, UK Monday 15th March and Tuesday 16th March 2010 |
| Monday 15th March | ||
| Session 1 | Chairs – Jeremy Whelan, Sigbjørn Smeland | |
| 1000-1030 |
Welcome, Introduction and Purpose • Rationale for new trials |
Neyssa Marina Stefan Bielack |
| 1030-1230 |
Studies and Activities Ongoing or In Development • 7 minute presentations from each group • Recent accomplishments and achievements • Lessons and reflections |
Group representatives ( ASSG, COG, EORTC, EURAMOS, GEIS, ISG, JCOG, SARC, SFCE/FNCLCC, SSG ) |
| 1230-1330 | Lunch | |
| Session 2A | Chairs – Stefan Bielack, Stefano Ferrari | |
| 1330-1350 | Biological Rationale for Future Studies | Anne Marie Cleton |
| 1350-1410 | Multi-Arm Multi-Stage Trials • A role for MAMS trials in rare diseases? |
Matthew Sydes |
| 1410-1430 | The need for international collaborations | Max Parmar |
| 1430-1500 |
Introducing New Study Proposals • Prioritising the research questions eg MTP, bisphosphonates, standard chemotherapies • Prioritising the designs • Prioritising trial ideas • Discussion of Concept Sheets |
All Submitters of Concept Sheets |
| 1500-1530 | Tea Break | |
| Session 2B | Chairs – Stefan Bielack, Stefano Ferrari | |
| 1530-1730 |
Discussion of New Study Proposals (continued) • Discussion of Concept Sheets |
All |
| 1730-1800 |
Partnerships • Collaboration methods and possibilities |
All |
| 1845 | Coach from Holiday Inn to Networking Dinner at Oxo Tower – dinner at 1900, prompt |
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| Future Clinical Trials for Adjuvant Treatment of Osteosarcoma – Prioritising the Questions Wellcome Collection, London, UK Monday 15th March and Tuesday 16th March 2010 |
| Tuesday 16th March | ||
| Workshop 1 | Chair – Jeremy Whelan | |
| 0800-0930 |
Study Opportunities in Metastatic/Recurrent Disease • Prioritising trial ideas • Discussion of Concept Sheets |
All + Submitters of Concept Sheets |
| Session 3 | Chairs – Neyssa Marina, Laurence Brugieres | |
| 0930-1030 |
Clarification of Group structures • 5 minute presentations from each group • Current group structure • Patient numbers • Funding mechanisms • Decision-making processes • Access to and use of mifarmutide |
Group representatives ( ASSG, COG, COSS, EOI, EORTC, EURAMOS, GEIS, ISG, JCOG, SARC, SFCE/FNCLCC, SSG ) |
| 1030-1100 | Tea Break | |
| 1100-1115 | EMRC and ESF | Maria Noguera |
| 1115-1145 | ECRIN | Jacques Demotes |
| 1145-1230 |
New Study Proposals – Revisited • Further reflections • Strengths and weakness of proposals and collaborations |
All |
| 1230-1330 | Lunch | |
| Workshop 2 | Chairs – Jeremy Whelan, Stefan Bielack, Neyssa Marina | |
| 1330-1600 |
Meeting of Lead Investigators for potential trial • Further development of trial proposal • Agreement of methods of moving forward |
Representatives of potential collaborative groups |
Concept Sheets for Potential New Studies
Concept A: Randomised controlled trial comparing standard of chemotherapy regimens (with mifamurtide) for osteosarcoma
Concept B: Randomised controlled trial of the optimal timing of mifamurtide (MTP)
Concept C: Randomised controlled factorial trial of combining standard chemotherapy regimens with or without MTP for osteosarcoma
Concept D: A four arm, phase 3 randomized trial of methotrexate, adriamycin and cisplatin (MAP) with zoledronic acid versus MAP with MTP-PE and zoledronic acid for newly diagnosed, localized osteosarcoma in children, adolescents and young adults
Concept E: Multi-Arm Multi-Stage trial of mifamurtide (MTP), zoledronic acid and 3- or 4-drug chemotherapy
Concept F: Multi-Arm Multi-Stage trial of mifamurtide (MTP) and zoledronic acid with 4-drug chemotherapy for osteosarcoma
Concept G: Pulmonary metastasectomy +/- systematic therapy for lung-only metastatic osteosarcoma
Concept H: Randomised phase II study of ridaforolimus (mTOR inhibitor) vs ridaforolimus and dalotuzumab (IGFR-1 antibody) in osteosarcoma