News
Osteosarcoma Strategy Group
A meeting of this group was held in Brussels on August 18 and 19. The purpose of the meeting was to discuss a proposed schema for the treatment of metastatic osteosarcoma in children and young adults and to obtain an agreement among the investigators attending this meeting:
- to participate in the conduct of a multi-national protocol;
- to finalize the treatment schema for the proposed protocol;
- to identify potential problems in managing a protocol involving widely dispersed countries with varied resources; and
- to discuss the strategic expansion of the work of the group in the future.
The investigators were from institutions in Brazil, Mexico, Saudi Arabia, India, China, Taiwan and the Philippines.
The rationale for beginning with patients with metastatic disease is to keep annual patient accrual to a manageable number whilst identifying the problems that undoubtedly will be faced in collecting accurate data in a timely fashion from so diverse a group, and developing strategies to overcome them.
During the meeting, the key elements of the protocol were discussed. These included:
- study objectives;
- the treatment schema;
- eligibility and exclusion criteria;
- ethical considerations;
- data management; and
- special biological and molecular studies.
A timetable for completion of the protocol document was established. A draft of the protocol document has been prepared and reviewed by a scientific panel. Investigators who participated in the development of the protocol have provided their feedback and responses to issues raised by the reviewers. Consultation with respect to data analysis has been obtained from a biostatistician and an oncology pharmacist has reviewed procedures for the administration of chemotherapy. The revised protocol will undergo review by an INCTR-appointed Ethical Review Committee in January 2001 and it is anticipated that a final draft, incorporating changes stipulated by the Ethical Review Committee, will be available shortly afterwards for review by participating centers. We anticipate that patient accrual will begin in late February or early March. Once satisfactory systems for data collection and quality control are in place, the protocol will be expanded to include non-metastatic osteosarcoma patients, patients from centers associated with the present core group, and additional participating centers from other countries.
