624 / 1119
INTERTECC Trial: Multi-centric International Study
• Phase II/III Trial of IMRT (45-50.4 Gy) with Cisplatin CT
• Stage I-IVA, Post-op or Intact
• Primary Endpoint: Acute G3 Heme + G2 GI Toxicity
• Target Accrual: 91 (Phase II) + 334 (Phase III) = 425
• Phase II: Single Arm (Lead-In)
• Translational Sub-Studies:
– Phase II Trial of Image-Guided BM-Sparing IMRT
– Validation of High-Dimensional Model of BM Toxicity
– Validation of Shape Model using Daily kV CBCT
• Phase III: Randomized Trial of BM sparing IMRT Vs. IMRT/ 3D CRT
• Central IMRT QA (MDA and Wash U.)