Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer
Conditions
Interventions
Patients are instructed to swish and expectorate new steroid-containing mouthwash 4 times daily. Treatment with new steroid-containing mouthwash start on Day 1 of everolimus -based therapy. Interven
Sponsors
Aichi Cnacer Center
Department of Gastroenterology, Aichi cancer center Department of Clinical Oncology, Aichi cancer center Department of Thoracic Oncology, Aichi cancer center Department of Head and Neck Surgery, Aichi cancer center Department of Pharmacy, Aichi cancer center Faculty of Bioscience and Bioindustry, Tokushima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of Pancreus, GI or lung origin 2.Pathologically confirmed advanced or metastatic renal cell carcinoma 3.Pathologically confirmed advanced or metastatic ER-positive and HER2-negatice breast cancer 4.ECOG performance status 0 or 1 5.Adequate bone marrow, liver and renal function 6.Informed consent is obtainable from the subject herself in documented form using the Consent Form
Exclusion criteria
Exclusion criteria: 1.Occurrence of oral mucositis within 1 month prior to randomization 2.Previous mTOR inhibitor treatment (everolimus, etc.) 3.Interstitial pneumonia or pulmonary fibrosis 4.Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) 5.Detection level of HBV-DNA 6.HCV infection or a history of HCV infection 7.History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation 8.Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 9.Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain 10.Pleural effusion, ascites, or pericardial effusion that requires emergency treatment 11.Concurrent and active infectious disease 12.With uncontrolled diabetes mellitus or currently receiving insulin therapy 13.Difficulty to participate in this study due to mental illness or psychiatric symptoms 14.With another reasons recognized as inadequate to participate in this study by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of greater than or equal to Grade2 stomatitis in 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of hydrocortisone containing mouthwash adjusted by the drugs approved in Japan. The incidence of stomatitis according to the tumor subtype. The site of stomatitis. The duration and severity of stomatitis | — |
Countries
Japan
Contacts
Public ContactMasaya Hattori
Aichi Cancer Center Department of Breast Oncology
Outcome results
None listed