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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)