Clinical trial protocol of doublet therapy and olanzapine for carboplatin-induced nausea and vomiting in patients with thoracic cancer: a multicentre phase II trial
| Autor: | Takenobu Gomyo, Momoko Yamada, Yasushi Ohno, Daizo Kaito, Mototsugu Shimokawa, Tomohiro Osawa, Tsutomu Yoshida, Yukiyoshi Fujita, Norihiko Funaguchi, Chiemi Hirose, Hirotoshi Iihara, Akio Suzuki, Koichi Minato |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Oncology vomiting medicine.medical_specialty Combination therapy Nausea olanzapine Antineoplastic Agents Granisetron Carboplatin Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Protocol medicine Clinical endpoint Humans 030212 general & internal medicine Aged business.industry General Medicine Middle Aged Thoracic Neoplasms Clinical trial Regimen chemistry 030220 oncology & carcinogenesis Vomiting Antiemetics Female medicine.symptom business medicine.drug |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionAdding neurokinin-1 receptor antagonist (NK1RA) to 5-hydroxytryptamine-3 receptor antagonist and dexamethasone (DEX) improved carboplatin (CBDCA)-induced chemotherapy-induced nausea and vomiting (CINV) in patients with thoracic cancer. NK1RAs with high-drug cost are raising medical expenses. Olanzapine (OLZ) is less expensive and can be expected to have an excellent effect on CINV. This phase II trial aimed at evaluating the efficacy and safety of 5 mg OLZ plus granisetron (GRN) and DEX in CBDCA combination therapy with area under curve (AUC) ≥5 mg/mL/min for the prevention of nausea and vomiting in patients with thoracic cancer.Methods and analysisThis is an open-label, single-arm, multicentre, phase II trial. Patients who receive CBDCA-based therapies (AUC ≥5) and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive a combination of GRN, DEX and OLZ. The primary endpoint is complete response (CR) rate, defined as the absence of emetic episodes and no use of rescue medication for 120 hours after the initiation of CBDCA. Forty-eight patients are required based on our hypothesis that this regimen can improve CR rate from 65% (null hypothesis) to 80% (alternative hypothesis) with a one-sided type I error of 0.1 and a power of 0.8. We set the target sample size at 50 considering dropouts.Ethics and disseminationThe study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberUMIN000031267. |
| Databáze: | OpenAIRE |
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