10 Research and Treatment Protocols

Question 1

4 major Peds Coopoerative groups for peds oncology clinical trials. What do they stand for?
CCG,POG,NTWS, and IRSG

Answer 1

Children’s Cancer Group, Pediatric Oncology Group, National Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Group. They all merged into COG

Question 2

Initial trial of a new agent in humans - study PK and eval toxicities and max dose. Unlikely to have a long-term positive effect for patient. Which phase?

Answer 2

Phase I

Question 3

This phase determines efficacy of treatment in a specific disease and further evals safety/toxicity

Answer 3

Phase II. pt must have a tumor that is measurable to eval effectiveness.

Question 4

This phase is most common in peds onc. Used to compare new treatment to standard treatment on a larger scale. Includes randomizations and stratification so every subject has equal chance of being assigned to each treatment.

Answer 4

Phase III.

Question 5

This phase is large scale to approve agent for widespread use. Rarely used in peds onc.

Answer 5

Phase IV.

Question 6

When does informed consent happen?

Answer 6

it is an ongoing process.

Question 7

What is the TDM?

Answer 7

Therapy delivery roadmap. aka roadmap.

Question 8

What is the usual age for obtaining assent?

Answer 8

7yo is the minumum