The percentage of total lung volume (the volume of both lungs minus the PTV) exceeding 20 Gy (V20) shall be < 30%. The total volume of the esophagus shall be contoured and the PTV should NOT be subtracted from this volume. The percentage of this esophageal volume exceeding 55 Gy (V55) shall be < 28% and the mean esophageal dose shall be < 32 Gy. Because the dose per fraction is increasing the V20 and V55 parameters as described above, they will need to be modified to account for this effect in normal organs, specifically lungs and esophagus. Since this study uses larger than standard fraction size, the V20 and V55 for lungs and esophagus respectively should be modified as follows.


Dose per fraction                     V20 becomes            V55 becomes
2. 0 Gy                                    V20                            V55
up to 2.25 (Arms 1-2)             V19                             V52
2.25 to 2.5 (Arms 3-4)             V18                            V50
2.5 to 2.9 (Arms 5-6)              V18                             V47
> 3.0 (Arms 7-8)                     V17                            V44


For example, if the patient is on arm 4 where the dose per fraction is 3.0 Gy, then the V17 for the total lung DVH must be less than 30% and the V44 for the esophagus must be less than 28%.

The tolerance of the lungs are related to the volume of the organ(s) irradiated.

Data from the Washington University reported that high-grade acute pneumonitis did not occur when the V20 was < approximately 30%. The incidence and the grade or severity of pneumonitis was clearly related to the V20. In the Washington University data, maximum dose (with conventional fractionation) was not related to acute pneumonitis. For this protocol all eligible patients must have the V20 < 30%. The esophagus volume (outer muscular contour) must be contoured from the level of just below the larynx to the gastro-esophageal juncture. Oral contrast at the time of scanning is necessary to delineate the esophagus. The percentage of the esophageal volume exceeding 55 Gy shall be < 28% and the mean esophageal dose shall be < 32 Gy. Because of the higher dose per fraction, the maximum spinal cord (point) dose should not exceed 35 Gy. Partial volume tolerance data for heart is not available. The heart dose should be kept as low as possible. Whole heart dose should not exceed 40 Gy. The liver dose should be kept to a minimum. Half the liver should not exceed 35 Gy. The whole liver should not exceed 30 Gy.

Chemotherapy: concurrent beginning day 1 with RT

Schema A: Paclitaxel 50 mg/m2, over 1 hour, days 1, 8, 15, 22, 29, 36, 43
Followed by Carboplatin AUC=2, over 30 minutes, days 1, 8, 15, 22, 29, 36, 43

Schema B: Paclitaxel 135 mg/m2, over 3 hours, days 1, 22, 43
Followed by Carboplatin AUC=5, over 30 minutes, days 1, 22, 43