Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

• DOI: 10.1186/s13014-022-02099-y
• Publication Date: 2022-07-29T20:02:43Z
• Authors: Hongcheng Zhu; Qiufang Liu; Hao Xu; Miao Mo; Zezhou Wang; Kui Lu; Jialiang Zhou; Junqiang Chen; Xiangpeng Zheng; Jinjun Ye; Xiaolin Ge; Honglei Luo; Qi Liu; Jiaying Deng; Dashan Ai; Shengnan Hao; Junhua Zhang; I Hsuan Tseng; Shaoli Song; Yun Chen; Kuaile Zhao
• Keywords: Chemoradiotherapy; Regimen

Definitive chemoradiotherapy has established the standard non-surgical treatment for locally advanced esophageal cancer. The dose of 50-50.4 Gy been decades ago and confirmed in modern trials. theorical advantage better local control technical advances less toxicity have encouraged clinicians escalation investigation. 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) potential to tailor therapy patients not showing response CRT pioneers PET-based escalation.The ESO-Shanghai 12 trial is a prospective multicenter randomized phase 3 study which are either 61.2 or 50.4 radiation by PET response. Both groups undergo concurrent with paclitaxel/cisplatin regimen 2 cycles followed consolidation chemotherapy cycles. Patients histologically ESCC [T1N1-3M0, T2-4NxM0, TxNxM1 (Supraclavicular lymph node metastasis only), (AJCC Cancer Staging Manual, 8th Edition)] without any prior chemotherapy, radiotherapy surgery against cancer will be eligible. primary endpoints included overall survival PET/CT non-responders (SUVmax > 4.0) total population. stratified standardized uptake volume, gross tumor volume location. enrollment could ended, when number non-responder reached 132 population 646 randomization.This approved Fudan University Shanghai Center Institutional Review Board. Trial results disseminated via peer reviewed scientific journals conference presentations. registration was initiated 2018 currently recruiting patients. NCT03790553.