ocr: I. Introduction and scientific background 2. Objectives 3. - Selection of patients 4. Design of study (including schematic diagram) 5. Treatment plan 6. Drug information 7. Toxicities to be monitored and dosage modifications 8. Required clinical and laboratory data and study calendar 9. Criteria for evaluating the effect of treatment and endpoint defi- nition 10. Statistical considerations 11. Informed consent and regulatory considerations 12. Data forms 13. References 14. - Study chairperson, collaborating participants, addresses, and tele- phone numbers
