Gynae BT_Lucknow_2018

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.)