Total neoadjuvant therapy for locally advanced gastric cancer and esophagogastric junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase II clinical trial

Autor: Jinming Shi, Ning Li, Yuan Tang, Liming Jiang, Lin Yang, Shulian Wang, Yongwen Song, Yueping Liu, Hui Fang, Ningning Lu, Shunan Qi, Bo Chen, Ziyu Li, Shixin Liu, Jun Wang, Wenling Wang, Suyu Zhu, Jialin Yang, Yexiong Li, Dongbing Zhao, Jing Jin
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMC Gastroenterology, Vol 22, Iss 1, Pp 1-9 (2022)
Druh dokumentu: article
ISSN: 1471-230X
DOI: 10.1186/s12876-022-02440-5
Popis: Abstract Background Gastric cancer ranks high in terms of morbidity and mortality worldwide. Multimodal therapy is therefore essential for locally advanced gastric cancer. Recent studies have demonstrated that both perioperative chemotherapy and neoadjuvant chemoradiotherapy can improve the prognosis of patients. However, the completion rate of chemotherapy after surgery remains low, which may affect survival. Thus, identifying the best way to combine radiotherapy, chemotherapy and surgery is important. The aim of this study was to explore the toxicity and efficacy of the total neoadjuvant therapy modality for locally advanced gastric cancer. Methods This study will be a prospective, multicenter, single-arm, phase II clinical trial. Patients diagnosed with locally advanced (stage cT3-4 and cN positive, AJCC 8th) gastric cancer and gastroesophageal junction adenocarcinoma will be enrolled. Patients will initially receive radiotherapy (95% planned target volume: 45 Gy/25 f) and concurrent chemotherapy (S-1: 40–60 mg twice a day) followed by six cycles of consolidated chemotherapy (SOX, consisting of S-1 and oxaliplatin) and surgery. The primary objective will assess pathological complete response; the secondary objectives will include toxicities assessing surgical complications, the tumor downstaging rate and the R0 resection rate. Discussion Investigation of total neoadjuvant therapy in gastric cancer is limited. The goal of this trial is to explore the efficacy and toxicity of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma. Trial registration: Clinicaltrials.gov (NCT04062058, August 20, 2019).
Databáze: Directory of Open Access Journals
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