A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared with Chemoradiotherapy in Locally Advanced Gastric Adenocarcinoma

Wang, X.; Jin, Jie; Zhao, Dan; Chi, Yihebali; Yang, Liang; Jiang, Longying; Dou, Lizhou; Tang, Yuan; Li, N.; Liu, W.; Tian, Yuan; Zhao, Hong; Che, Xu; Bai, Xiaofeng; Liu, Ningning; Ren, Hua; Fang, H.; Wang, S.L.; Song, Yan; Liu, Y.; Li, Y.X.

doi:10.1016/j.ijrobp.2018.06.057

Cited by 2 publications

(3 citation statements)

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“…The disease-free survival rate (87.1% vs. 63.9%, P = 0.05) and local tumor-free survival rate (100% vs. 73.3%, P = 0.014) in the NCRT group were better than those in the NCT group. No grade V reaction or perioperative death occurred in either group [ 20 ]. This research laid a methodological foundation and provided data to calculate the sample size in this study.…”

Section: Discussionmentioning

confidence: 99%

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

Shi

Tang

et al. 2022

BMC Gastroenterol

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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).

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Section: Discussionmentioning

confidence: 99%

“…The primary objective is to determine the pCR rate in this trial. According to the results of the prospective phase II trial previously conducted at our center [ 20 ], the pCR rate of patients who received NCT was 14% (P0). We assume that after NCRT and six cycles of NCCT, the pCR rate will reach 28% in this study.…”

Section: Methodsmentioning

confidence: 99%

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

Shi

Tang

et al. 2022

BMC Gastroenterol

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“…In the RESOLVE study [ 85 ], EGJ cancer patients comprised 36.5% of the study population, suggesting that perioperative chemotherapy could also be an effective treatment in the Asian population. For adenocarcinomas of the EGJ or squamous cell carcinoma in the middle to lower esophagus, clinical research supports neoadjuvant chemoradiotherapy followed by surgery and adjuvant chemotherapy to effectively achieve tumor downstaging, improve R0 resection rate and prolong OS, without increasing postoperative complications or mortality rates [ 117 , 118 ], and it is considered the standard treatment. Long‐term follow‐up results from the German POET study [ 119 ], which involved neoadjuvant chemoradiotherapy combined with adjuvant chemoradiotherapy versus neoadjuvant chemotherapy for esophagogastric adenocarcinomas (Siewert I‐III), suggest a tendency towards reduced recurrence and prolonged survival compared to neoadjuvant chemotherapy alone, with no significant increase in treatment toxicity or perioperative complications.…”

Section: Comprehensive Treatment Of Gastric Cancermentioning

confidence: 99%

The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023

Wang,

Zhang,

Tang

et al. 2023

Cancer Communications

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The 2023 update of the Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines for Gastric Cancer focuses on standardizing cancer diagnosis and treatment in China, reflecting the latest advancements in evidence‐based medicine, healthcare resource availability, and precision medicine. These updates address the differences in epidemiological characteristics, clinicopathological features, tumor biology, treatment patterns, and drug selections between Eastern and Western gastric cancer patients. Key revisions include a structured template for imaging diagnosis reports, updated standards for molecular marker testing in pathological diagnosis, and an elevated recommendation for neoadjuvant chemotherapy in stage III gastric cancer. For advanced metastatic gastric cancer, the guidelines introduce new recommendations for immunotherapy, anti‐angiogenic therapy and targeted drugs, along with updated management strategies for human epidermal growth factor receptor 2 (HER2)‐positive and deficient DNA mismatch repair (dMMR)/microsatellite instability‐high (MSI‐H) patients. Additionally, the guidelines offer detailed screening recommendations for hereditary gastric cancer and an appendix listing drug treatment regimens for various stages of gastric cancer. The 2023 CSCO Clinical Guidelines for Gastric Cancer updates are based on both Chinese and international clinical research and expert consensus to enhance their applicability and relevance in clinical practice, particularly in the heterogeneous healthcare landscape of China, while maintaining a commitment to scientific rigor, impartiality, and timely revisions.

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A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared with Chemoradiotherapy in Locally Advanced Gastric Adenocarcinoma

Cited by 2 publications

References 0 publications

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

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

The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023

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