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The clinical outcome based on the treatment course factors in CLASSIC trial.
Proposal
7080
Title of Proposed Research
The clinical outcome based on the treatment course factors in CLASSIC trial.
Lead Researcher
Hisaka Akihiro
Affiliation
Laboratory of Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
19 May 2020
Lay Summary
The purpose of this research is to find factors that influence the efficacy of adjuvant chemotherapy for gastric cancer. Gastric cancer is the fifth most common cancer in the world and is a major cause of cancer-related death. In 2012, there were approximately 952,000 new cases of gastric cancer worldwide (631,000 men and 320,000 women) with 723,000 deaths (469,000 men and 254,000 women), making it the third-leading cause of cancer death globally in both sexes<ref1>.The incidence of gastric cancer in Japan was estimated at 29.9 per 100,000 in 2012, giving Japan the third highest incidence in the world. <ref2>Adjuvant chemotherapy is a standard treatment in Asia for patients with stage II/III gastric cancer after D2 gastrectomy on the basis of CLASSIC trial<ref3> and ACTS-GC trial<ref4,5>. In both CLASSIC trial and ACTS-GC trial, patients were randomly assigned (1:1) to receive adjuvant therapy group or observation group, and the adjuvant therapy show to improve disease-free survival and overall survival significantly compared with observation group.However, there are still rooms for improvement since approximately 40% patients were relapsed within 5 years after the gastrectomy. In classic trial, it has been reported that the factors of dose, administration delay and treatment discontinuation do not show a significant difference in terms of disease-free survival and overall survival, but detailed factors based on each patient treatment course have not been reported. Especially, responsiveness including safety markers to the chemotherapy have not been considered as predicting factors of the final outcome. So, we would like to request such data to CSDR and will conduct the analysis of each patient treatment course based on the data to find the influencing factors to improve survival benefit.
Study Data Provided
[{ "PostingID": 4263, "Title": "*SANOFI-MO17527/L_9570", "Description": "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" },{ "PostingID": 5067, "Title": "ROCHE-MO17527 (L_9570)", "Description": "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" }]
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