Protocol of OGSG 1901: a phase II trial of ramucirumab plus irinotecan for patients with early relapsed gastric cancer during or after adjuvant docetaxel plus S - 1 therapy

• Published in: BMC cancer Vol. 22; no. 1; pp. 773 - 6
• Main Authors: Yamaguchi, Toshifumi, Kawakami, Hisato, Sakai, Daisuke, Kurokawa, Yukinori, Shimokawa, Toshio, Goto, Masahiro, Satoh, Taroh
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15.07.2022; BioMed Central; BMC
• Subjects: Adenocarcinoma; Angina pectoris; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Ascites; Cancer therapies; Care and treatment; Chemotherapy; Chemotherapy, Adjuvant; Clinical trials; Clinical Trials, Phase II as Topic; Creatinine; Diagnosis; Docetaxel; Dosage and administration; Drug dosages; Early relapse; Gastrectomy; Gastric cancer; Gastrointestinal surgery; Hematology; Humans; Hypertension; Immunotherapy; Irinotecan; Irinotecan - therapeutic use; Medical prognosis; Mental disorders; Monoclonal antibodies; Multicenter Studies as Topic; Neoplasm Recurrence, Local; Patient outcomes; Patients; Prospective Studies; Ramucirumab; Registration; S-1; Stomach cancer; Stomach Neoplasms - pathology; Study Protocol; Survival; Targeted cancer therapy; Thromboembolism; Japan; Irinotecan; Ramucirumab; Early relapse; Gastric cancer; S-1; Docetaxel
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-022-09844-2

Although docetaxel plus S-1 adjuvant chemotherapy after gastrectomy with D2 lymphadenectomy has been a standard of treatment for stage III gastric cancer, there is no established chemotherapy for patients with recurrence during or within six months after the completion of adjuvant docetaxel plus S-1 therapy. The OGSG 1901 trial is a prospective, open-label, multicenter, phase II trial evaluating ramucirumab plus irinotecan for gastric cancer patients with early relapse after adjuvant docetaxel plus S-1 therapy. The key eligibility criteria were: 1) histologically confirmed gastric adenocarcinoma 2) patients who were on docetaxel plus S-1 adjuvant chemotherapy after the confirmation of pathological stage III, 3) patients with early relapse, i.e., recurrence during or within 6 months after the completion of docetaxel plus S-1 therapy, and 4) patient with Eastern Cooperative Oncology Group performance status of 0-1. Irinotecan (150 mg/m , day 1) and ramucirumab (8 mg/kg, day 1) will be administered every 2 weeks. The primary endpoint is overall survival, and the secondary endpoints are overall response rate, progression-free survival, and safety. The number of patients has been set at 40 based on the threshold and expected median survival times of 7 and 11 months, respectively, with a one-sided alpha error of 0.05 and power of 0.80. The enrollment and follow-up periods are 2 and 1.5 years, respectively. The results of this trial will indicate whether the ramucirumab with irinotecan regimen has the potential to be a recommended treatment regimen for patients with recurrence gastric cancer during or within 6 months after the completion of adjuvant docetaxel plus S-1 therapy. This study was registered in the Japan Registry of Clinical Trials ( jRCTs05119071 , October 6, 2019).