View clinical trials related to Colorectal Cancer Metastatic.
Filter by:This is a phase IV multicenter trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population. The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab. During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.
This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). This study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. First, it will enable to assess the economic impact of panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (Blood study). The primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. The blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab and will participate to the HEOR study and to the blood biomarker study. During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. For patients participating to the blood study (patients with a wild type KRAS), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.
Primary Objective: Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept. Secondary Objectives: To evaluate: - Efficacy: Progression Free Survival (PFS) - Efficacy: Overall Survival (OS) - Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria - Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L - Safety Exploratory Objective: To collect blood and tumor samples to perform investigations for potential biomarker testing.
Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm. Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries. The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated. This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
Primary Objectives: Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study. Study Part 2: To assess the percentage of patients without progression of the disease at 6 months after the start of maintenance therapy with aflibercept single-agent, following the first-line induction therapy with XELOX and aflibercept combination in patients with previously untreated metastatic colorectal cancer. Secondary Objective: Study Part 2: Include the evaluation of progression free survival, overall survival, response to treatment, the overall safety (during induction and maintenance therapy) and the assessment of aflibercept pharmacodynamics and biomarkers parameters.
Adenocarcinoma of the colon and rectum is a common, serious disease and it is the second cause of death from cancer in Spain. The prognosis of CRC depends to a great extent on its stage when diagnosed. Patients with advanced disease, who present up to 40% of all patients, have a poor prognosis. Although the application of modern chemotherapy and radiotherapy treatments obtains median survival periods of around 24 months, the proportion of patients with advanced disease who obtain a cure is low. Systemic treatment of advanced CRC has changed considerably in the last ten years with the introduction of active drugs such as oxaliplatin, irinotecan, and capecitabine. The most commonly used first line regimens are 5-Fluorouracil-Leucovorin-Oxaliplatin (FOLFOX), Capecitabine-Oxaliplatin (XELOX), 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) and, to a lesser extent, Capecitabine-Irinotecan (XELIRI). Chemotherapy regimens are combined with different agents against therapeutic targets, three of which are effective in colon cancer: bevacizumab, which targets vascular endothelial growth factor (VEGF) and cetuximab or panitumumab, which target the epidermal growth factor receptor (EGFR). The use of cetuximab and panitumumab is not recommended in patients with KRAS mutations and the combination of a VEGF and EGFR agents is not beneficial. Two recent studies results have identified KRAS mutations as frequent drivers of acquired resistance to cetuximab and panitumumab in colorectal cancer patients. The conclusions indicate that the emergence of KRAS mutant clones can be detected non-invasively months before radiographic progression by a DNA Blood Test (Inostics´BEAMing Technology). Centro Integral Oncológico Clara Campal (CIOCC) is aiming to undertake a pioneer project aimed at integrating the analysis of KRAS switch status by BEAMing Technology in patients with metastatic colorectal cancer, tumor KRAS wild-type and BEAMing wild-type treated with first line FOLFIRI-cetuximab In naive chemotherapy tumor-KRAS wild-type metastatic colorectal cancer patients, who are BEAMing positive (KRAS mutated in blood) before treatment may have worse evolution in terms of PFS (progression Free Survival) and response rate than BEAMing negative (KRAS native in blood) patients. To know the proportion of patients who are BEAMing positive (KRAS mutation can be detected in circulating extracellular DNA) at the beginning of treatment, could be of great importance for treatment efficacy.
Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing. Results will be discussed during a molecular screening tumor board.
STRATEGIC-1 is a study designed to determine the best sequence of therapy in patients with metastatic colorectal cancer.
Study Design: Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and safety of Gemcitabine/Pemetrexed combination. Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12 cycles lasting 2 weeks). Total duration of the study: 24 months. Number of Subjects: Approximately 38 subjects will be enrolled on study: - First stage:12 patients enrolled If 1 or 0 responses were observed, the trial had to be terminated: - Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were observed in 35 patients, the combination would not be considered worthy of further study, while if 6 or more responses were observed, the combination would be considered sufficiently active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients will be needed for this step.