Abstract
BackgroundPaclitaxel is used in second-line conventional chemotherapies to manage patients with unresectable advanced gastric cancer (GC). Paclitaxel-induced peripheral neuropathy is a known adverse event leading to treatment discontinuation. Additionally, oxaliplatin which causes irreversible peripheral neuropathy is now commonly used in first-line chemotherapy for advanced GC in Japan. Thus, examining the incidence of peripheral neuropathy with paclitaxel after oxaliplatin is necessary to improve the quality of life and outcomes of patients with advanced GC in the second-line treatment setting.MethodsThis prospective observational multicenter study, (which we named IVY study), will evaluate the degree of chemotherapy-induced peripheral neuropathy (CIPN) and the efficacy of second-line chemotherapy for unresectable advanced GC. A patient neurotoxicity questionnaire (PNQ) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) will be used to assess CIPN during the second-line treatment. The key eligibility criteria are as follows: 1) unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach, 2) age over 20 years, 3) Eastern Cooperative Oncology Group performance status score of 0–2, 4) written informed consent following full study information is provided to the patient, 5) progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC. 6) presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging. A total of 200 patients is considered to be appropriate for inclusion in this study.DiscussionThe results of this study will provide some information on CIPN with the sequential usage of oxaliplatin as first-line chemotherapy to paclitaxel as second-line chemotherapy in clinical practice.Trial registrationThis trial is registered in the University Hospital Medical Information Network’s Clinical Trials Registry with the registration number UMIN000033376 (Registered 11 July 2018).
Highlights
Paclitaxel is used in second-line conventional chemotherapies to manage patients with unresectable advanced gastric cancer (GC)
In the first-line setting of advanced GC, a randomized phase III trial of doublet therapy with CS or S-1 with oxaliplatin (SOX) showed that oxaliplatin was as effective as cisplatin concerning overall survival (OS) and progression-free survival (PFS) [16]
Oxaliplatin-induced Chemotherapy-induced peripheral neuropathy (CIPN) is characterized by dose-dependent symptoms that worsen after the end of treatment [17]
Summary
Study design and assessment The primary endpoint is the incidence of grade 3–4 CIPN in second-line chemotherapy. Patients will answer the PNQ and the FACT/GOG-Ntx questionnaires before treatment (baseline) and every treatment cycle. Statistical methods As mentioned, of the patients who enrolled in this study, the patients with or without any degree of CIPN will be estimated 1: 2 population at the start of second-line chemotherapy administration. We estimate the incidence of grade 3–4 CIPN with 8% (SD + 8%) of the enrolled patients without CIPN at the start of second-line chemotherapy administration during the second-line treatment of PTX with Ramucirumab group (control group). The CIPN assessments will be performed at baseline and before every cycle using the PNQ, FACT/GOG-Ntx, and CTCAE during the treatment period
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