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Oxaliplatin

Capecitabine

Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy

3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 D1; 21-days/cycle) following with D2 Gastrectomy and 3 cycles of Adjuvant XELOX Chemotherapy

Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Neoadjuvant Chemoradiotherapy

3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)

Neoadjuvant Chemotherapy

R0 D2 Gastrectomy

Adjuvant Chemotherapy

Zhi-wei Zhou, M.D, Ph.D

Wei Wang, M.D, Ph.D

Zhi-wei Zhou, MD,PhD

Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

Background: Literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear.

Patients and methods: In this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are cT3N2/N3M0, cT4aN+M0 and cT4bNanyM0, aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy (Capecitabine 1000mg/m2, BID, D1-14; Oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using XELOX regimen following by D2 gastrectomy and adjuvant chemotherapy with same dosage of XELOX therapy for up to 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

Neoadjuvant Chemoradiotherapy versus Neoadjuvant Chemotherapy

Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

An Randomized, Multicenter, Open-label, Phase III Trial Comparing Neoadjuvant Chemoradiotherapy Versus Chemotherapy in Patients With Locally Advanced Gastric Adenocarcinoma

Guangdong Provincial People's Hospital

The First Affiliated Hospital of Anhui Medical University

Liaoning Cancer Hospital & Institute

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangxi Medical University Cancer Center

Tianjin Medical University Cancer Institute & Hospital

Zhejiang Cancer Hospital

First Hospital of China Medical University

First People's Hospital of Hangzhou

Sun Yat-sen University

Director of Gastric Surgery

Trastuzumab

Antimetabolites

Antineoplastic Agents, Immunological

Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle).

Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.

Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14\~16 cycles.

Capecitabine 800\~1000 mg/m² is given orally twice a day for 14 days followed by a 1-week rest.

Number of cycles: 8 cycles.

Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.

Number of cycles: 8 cycles.

Guanghai Dai, PHD

Yan Shi, PHD

Guanghai Dai

Yan Shi

The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.

Gastric cancer is the second leading cause of cancer death worldwide. Highest incidence rate is observed in Eastern Asia.

D2 gastrectomy has been established as a standard surgical procedure. While recurrence rate after resection is still high.

The CLASSIC study showed that Xelox regimen after D2 gastrectomy improves 3-year disease-free survival compared with surgery only. But patients with late stage still have poor prognosis according to subgroup analysis and our retrospective study.

HER2 is an important biomarker and key driver of tumorigenesis in 7-34% gastric cancers. The ToGA study showed that trastuzumab, a monoclonal antibody that targets HER2, plus chemotherapy improved overall survival(16.0m vs 11.8m) in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.

Based on previous experiences of trastuzumab in adjunctive therapy of breast cancer and ACTS/CLASSIC/ToGA studies, we suppose that trastuzumab plus XELOX as adjunctive treatment may benefit patients with HER2-positive Stage III gastric cancer after D2 Gastrectomy.

According to the above, we do this single-arm research to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.

T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.

Defined as the time from study treatment to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause.

Measure of time from study treatment to patient's death or lost to follow-up.

Percentage of patients who experience adverse events during this study.

assessment of the relationship between biomarker status and prognosis

Chinese PLA General Hospital

Professor and chief physician

Patients are managed by radical gastrectomy with D1 lymphadenectomy

Patients are managed by radical gastrectomy with D2 lymphadenectomy

Radical gastrectomy with D1 lymphadenectomy

Radical gastrectomy with D2 lymphadenectomy

Mohamed Elmessiry, MD

Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Frequency of early postoperative complications

Frequency of early postoperative mortality

Frequency of tumor recurrence within 5 years after curative surgery

Frequency of Cancer specific mortality within 5 years after curative surgery

Percentage of patients survived for 5 years after surgery without tumor recurrence

Percentage of patients survived for 5 years after surgery with/without tumor recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer	NCT01815853	Gastric Cancer	Neoadjuvant Che... Neoadjuvant Che... R0 D2 Gastrecto... Adjuvant Chemot...	18 Years - 75 Years	Sun Yat-sen University
Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer	NCT01815853	Gastric Cancer	Neoadjuvant Che... Neoadjuvant Che... R0 D2 Gastrecto... Adjuvant Chemot...	18 Years - 75 Years	Sun Yat-sen University
T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy	NCT02250209	Gastric Cancer	Trastuzumab Capecitabine Oxaliplatin	18 Years - 80 Years	Chinese PLA General Hospital
D2 Versus D1 Gastrectomy of Operable Gastric Cancer	NCT04429841	Gastric Cancer	Radical gastrec... Radical gastrec...	20 Years - 80 Years	Alexandria University

Spots Global Cancer Trial Database for d2 gastrectomy