View clinical trials related to Metastatic Disease.
Filter by:This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with metastatic disease. Patients will have had no previous chemotherapy for metastatic esophagogastric cancer. Patients will receive nintedanib or placebo in combination with mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression. The primary objective is to test the hypothesis that progression free survival (PFS) is prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in the pooled arms.
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study. This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment. The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.