Study design
tumor, adenopathy
DISEASE PROGRESSION, TUMOR, DISEASE, METASTATIC DISEASE, ADENOPATHY, PRIMARY TUMOR, DISEASE, GASTROINTESTINAL CANCER
Oregon Health & Science University (OHSU) Gastrointestinal Cancer Disease Group undertook a single‐arm, open‐label phase 2 trial (NCT02427841) in Portland, Oregon, enrolling patients from March 17, 2016 to October 5, 2019. Patients were scheduled to initially receive preoperative chemotherapy with gemcitabine 1000 mg/mIf patients experienced no disease progression radiographically following 2 months of chemotherapy, they then proceeded with preoperative chemoradiation with 50.4 Gy intensity‐modulated radiation therapy over 28 daily fractions of 1.8 Gy per fraction. Radiation therapy treatment volumes consisted of the primary tumor and clinically involved regional adenopathy >10 mm on the baseline (prechemotherapy) imaging (i.e., gross tumor volume [GTV]). No nodal regions were irradiated prophylactically. An additional 10 mm expansion was utilized on the GTV to encompass microscopically involved disease (clinical target volume). Finally, a 20 mm cranial‐caudal expansion and 10 mm axial expansion were utilized to account for respiratory motion and set‐up inaccuracies (planning target volume). Daily image guidance with cone‐beam CT was performed. Patients received concurrent IV 5‐fluorouracil 225 mg/mIf no evidence of metastatic disease was noted following neoadjuvant chemotherapy and chemoradiation, patients subsequently underwent definitive resection within 4–12 weeks followed by an additional four cycles of gemcitabine and nab‐paclitaxel postoperatively upon clinical recovery. Study schema is graphically presented in Figure This study was done in accordance with the Declaration of Helsinki and was approved by local institutional review board at OHSU. All participants completed written informed consent prior to initiating any research procedures.