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Proposal 1601

Title of the Proposed Research

Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patents’ data from large randomized controlled trials

Lead Researcher

Akira Tsuburaya, MD PhD

Affiliation

Tsuboi Cancer Center Hospital

Funding Source

None, planned to be provided by Japanese Gastric Cancer Association, JGCA

Potential Conflicts of Interest

None

Data Sharing Agreement Date

14 September 2017

Lay Summary

We aim to analyze clinical markers to choose the most effective additional treatment for patients who underwent curative surgery for stomach cancer. Stomach cancer is the fourth most common cancer worldwide and the second leading cause of cancer-related deaths due to its poor prognosis overall. Guidelines recommend additional drug therapy for advanced and curatively resected tumors, mostly stage II and III, by the robust evidence from each clinical trial. Since surgical procedures and additional drugs were different among the trials, the recommendations are also different with no global standard. Recently, the West and East have collaborated to standardize cancer staging and surgical procedures to dissect lymph nodes (D2). D2 is systematic removal of lymph nodes around stomach and pancreas to prevent local and regional tumor regrowth.

The profiles (trial name: countries, published year, % D2; and treatment) of the robust clinical trials are as follows.

a) INT 0116: USA, 2001, 10%; FU and radiation
b) MAGIC: Europe, 2006, 38%; Epirubicin, Cisplatin and FU
c) ACTS-GC: Japan, 2007, 100%; S-1
d) CLASSIC: Korea and China, 2012, 100%; Capecitabine and Oxaliplatin
e) SAMIT: Japan, 2014, 100%; UFT, S-1 and Paclitaxel

Among the three trials recruited D2 received patients; proportion of advanced disease was different. % stage III was 55% in ACTC-GC, 50% in CLASSIC, and 60% in SAMIT, respectively. The subgroup analysis in ACTS-GC suggested that treatment might have less effect in patients with stage III than in those with stage II disease, while the effects between the stages were similar in CLASSIC. In SAMIT, combined therapy was more effective than monotherapy for stage III. Since preventive drug therapy after stomach resection is highly stressful for patients, physicians have to predict the most efficient treatment for each patient. Several treatments after surgery have been accepted by health insurance in the world, but there is no guideline for treatment selection. Since comparing treatments by a new clinical trial takes long time, it is important to identify clinical markers from finished good trials now. Considering surgical procedures, we plan to analyze the three Asian trials altogether. By using each patient background, treatment and progress; we could identify useful clinical markers for treatment selection to support patients with stomach cancer.

Study Data Provided

*SANOFI-MO17527/L_9570: A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin versus Surgery Alone in Patients with Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0), and IIIb (T3N2) Gastric Adenocarcinoma

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.