SARC: Participation and Protocol / Concept Review

Robert Maki, MD PhD Memorial Sloan-Kettering Cancer Center

SARC Characteristics

• • 501(c)(3) non-profit organization

Guiding principle

: Those sites with a large volume of sarcoma patients seen by dedicated experts will perform the best quality research studies and most rapidly improve patient care • Organization run by a Board of Directors – To be differentiated from a Membership organization • As a result, you cannot be a

Member

of SARC • However, it is possible to be a

Participant

in SARC

Participation in SARC

• Until now, we have not had well-defined criteria to determine if a site should be considered for SARC participation – An admittedly significant shortcoming • The Board of Directors named three people to address this issue – Suzanne George (DFCI) – Paul Meyers (MSKCC) – Robert Maki (MSKCC) • We drafted and reviewed criteria, and present those to you now

SARC Participation criteria

• Cover letter • At least 4 CTOS members, assigning one PI: – Medical or Pediatric oncology – Surgery – Pathology – Radiology • Treat 40 cases per year at your center • European Participants must be part of EORTC or agree to follow its guidelines for the study at hand • Update annually the site’s case numbers/staff • Participate in at least one SARC meeting a year

1 2 3 4 Date (month/day/year XX/YY/ZZZZ): Institution Name: Type of participant (Participant, Single Protocol Participant) Site Principal Investigator (PI): 5 Participants--add lines as needed:

Medical Oncologist: Pediatric Oncologist: Pathologist: Surgical Oncologist: Orthopedic Oncologist: Radiologist: Radiation Oncologist:

6 American College of Surgeons Annual Statistics or other indication of cases treated

Number of New Sarcoma Patients 2004-2005 Number of Sarcoma Patients Treated 2004-2005

7 Therapeutic Trials since January 2004 (add more space as needed)

Protocol Name Sponsor Number of patients enrolled

CTOS Member?

Co PI?

Source of data

Single protocol participant

• Allows sites without all the expertise of a larger center to participate in an individual study – Useful when an investigator, well known to a SARC participant, wishes to take part in a study • How single protocol participants are identified – SARC Participant site nominates the Single Protocol Participant – Requires Executive Board approval – The SARC Participant is responsible for review of radiology and pathology for patients enrolled on the study at the Single Protocol Participant site

Protocol Concepts and Protocols

SARC Executive Board Responsibilities

• To insure that each protocol maintains the highest level of scientific merit.

• To insure that each clinical trial has an appropriate statistical section.

• To establish programmatic priority for each clinical protocol with respect to other SARC protocols • To insure that the data to be collected are appropriate to the study’s goals.

• To monitor the progress of SARC protocols.

• To recommend closure of trials that have met accrual goals, have poor accrual, have reached and early stopping point or have not maintained scientific standards or priority.

Protocol evaluation: how to do it

• Submit a concept to the SARC Administrative office – The list of data needed for this submission follows • Executive Board evaluates – Scientific merit – Prioritization – Resources available to perform the study • Concept discussed at following Monthly conference call • If Concept is approved → the PI is invited to write and submit a full protocol • Protocol reviewed at subsequent Conference Call • Protocol is the reviewed / opened at PI’s home site in anticipation of other SARC sites following • Protocol will be posted with support documents on SARC web site

Concept sheet (1)

1. Date of Submission 2. Name of Principal Investigator (PI), PI contact information 3. Names and contact information for co-Principal Investigators 4. Title of proposed Clinical Trial 5. Phase of research study (pilot, I, II, etc.) 6. Lead Institution and Address 7. Research Sponsor 8. Agents to be employed in the clinical trial; indicate if a specific agent is investigational 9. Disease / subtypes to be investigated 10. Performance Status limitations

Concept sheet (2)

11. Prior therapy permitted – We encourage patients with prior therapy for appropriate new agents, since many new agents will work independent of number of prior lines of standard cytotoxic (or other systemic) therapy 12. Age of participants in the clinical trial – SARC encourages the enrollment of subjects under age 18 when feasible.

13. Abnormal organ function permitted 14. Proposed Sample Size (minimum, maximum if appropriate) and estimated monthly accrual 15. Estimated date of 1st patient enrollment 16. Rationale for Study 17. Treatment Plan 18. Correlative Science 19. Endpoints and statistical consideration – Novel trial designs are welcome

Protocol and Consent form 1. May use CTEP NCI format or similar 2. May be an industrially sponsored protocol as long as it addresses the same issues as 1.

SARC Participation

• Many institutions have expressed their interest in participating, and we are grateful for the receipt of 4 or 5 recent applications • E-mail SARC office with your interest – We hope to process the present group of applications this month • Hopefully this will codify the roster of SARC participants, so that we can more transparently perform research