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Table 2 Summary of variation in selection criteria for cardiopulmonary and respiratory tests by protocol amendment

From: Phase II trial of neoadjuvant pemetrexed plus cisplatin followed by surgery and radiation in the treatment of pleural mesothelioma

Selection criteria Before protocol amendment After protocol amendment
FEV 1 >2 L, or >35% of predicted postoperative (ppoFEV1); if < 2 L, the ppoFEV1 must be at least 35% based on the following formula using the quantitative V/Q scan: Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report. > 0.8
DLCO > 35% of ppoFEV1  
ABG pCO2 < 50 predicted postoperative pCO2 < 50
Adequate cardiac function The patient's cardiac function and presence or absence of coronary artery disease or valvular heart disease should be assessed by one of the following tests: The patient's cardiac function and presence or absence of coronary artery disease or valvular heart disease should be assessed by the following tests:
 · Radionuclide stress test: preferred  · Echocardiogram (mandatory): Ventricular Ejection Fraction 3 45%
 · Exercise stress test to maximal exercise level  · Electrocardiogram (mandatory)
 · Stress echocardiogram  · Radionuclide stress test (optional)
    · Exercise stress test to maximal exercise level (optional)