Index 
Schema 
1.0 Background 
2.0 Goals 
3.0 Patient Eligibility 
4.0 Test Schedule 
5.0 Stratification Factors 
6.0 Registration/Randomization Procedures 
7.0 Protocol Treatment 
8.0 Treatment Modification Based on Toxicity 
9.0 Ancillary Treatment 
10.0 Toxicity Monitoring and Adverse Reaction Reporting 
11.0 Treatment Evaluation 
12.0 Descriptive Factors 
13.0 Treatment/ Follow-Up Decision at Evaluation of Patient 
14.0 Pharmacologic Studies 
15.0 Drug Information 
16.0 Statistical Consideration and Methodology 
17.0 Pathology Consideration 
18.0 Data Collection Procedures 
References 
Common Toxicity Criteria 
Appendix I - Kamofsky Performance Scale 
Appendix II - WHO recommendations for Grading of Acute and Sub-acute Toxic 
Effects 
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