9.0 CRITERIA FOR DISCONTINUING THERAPY 
9.1 Increasing endobronchial tumor (greater than 25% increase in product of 
perpendicular diameters) after a minimum of 2 or more courses of therapy. 
9.2 The development of unacceptable toxicity defined as unpredictable, irreversible, 
or Grade 4. Patient refusal of therapy due to a specific toxicity should be 
graded as 4 and an explanatory note recorded. 
9.3 Non-compliance by patient with protocol requirements. 
9.4 Patient refusal to continue treatment. 
9.5 Criteria for removal from protocol: 
a) Refusal to continue study participation 
b) Significant hemoptysis 
c) Coagulopathy 
d) Progressive postobstructive pneumonia 
10.0 DATA AND PROTOCOL MANAGEMENT 
10.1 Protocol Compliance: The attending physician and oncology research nurse 
must see patients prior to drug administration. All required interim and 
pretreatment data should be available and the physician must have a 
designation as to tumor response and toxicity grade. 
10.2 Data Entry: Data must be entered into the Clinical Data Management System 
before a course of therapy can be given. A brief explanation for missing data 
should be recorded as a comment. 
10.3 Accuracy of Data Collection: The Study Chairperson will be the final arbiter of 
response of toxicity should a difference of opinion exist. 
10.4 Statistical Considerations: A single arm study design will be used. It is assumed 
that the regrowth of the tumor occurs in 90% of patients (>25% increase in 
area). If the frequency of regrowth is reduced to 60% by the treatment, then 
using a one-sided test with 80% power and a =.05, a sample size of 14 patients 
is needed. It should be possible to accrue this number within 18 months. 
To prevent enrolling more patients in the trial when excessive toxicity is found, a 
Bayesian early stopping rule will be implemented. The design is described as 
follows: 
1) The toxicity is considered unacceptable at the level when more than one- 
third of the patients develop Grade 3 toxicity or when more than one- 
sixth of the patients develop Grade 4 toxicity. 
Recombinant DNA Research, Volume 16 
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