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Aims: To assess the safety and efficacy of chemo-radiotherapy before radical surgery in locally advanced gastric and gastroesophageal adenocarcinoma.
Study Design: This was a prospective phase Ⅱ single arm study.
Place and Duration of Study: Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Mansoura, Egypt, between May 2017 and June 2019.
Methodology: Patients with pathologically proven gastric or gastroesophageal junction adenocarcinoma are included. They received one cycle of induction chemotherapy paclitaxel-carboplatin, [paclitaxel dose of 175 mg/m2, carboplatin dose of (AUC: 5)], followed by CCRT [RT 45 Gy over 25 fractions over 5 weeks concurrent with weekly paclitaxel at a dose of 50 mg/m2, carboplatin at a dose of (AUC: 2)], followed by surgery and 2 cycles of paclitaxel-carboplatin for responders.
Results: The study included 24 patients. Most of the patients were diagnosed at stage III (83.3%). There were no major side effects of the induction chemotherapy cycle. There were no reported grade 3 or 4 toxicities for the CCRT. Only two patients suffered from late radiation toxicities (distal esophageal stenosis). Pathological complete response was achieved in seven patients (31.8%). Twenty-two patients had surgical resection with a 95% resection margin zero. The median follow-up time was 22.5 months. The median progression-free survival (PFS) and overall survival (OS) were 23, 23.5 months, respectively.
Conclusion: The preliminary data suggested good efficacy of the studied treatment design with acceptable adverse-event rates, however a larger multicentric phase 3 trial with a longer follow-up duration is recommended.