View clinical trials related to Colorectal Neoplasms.
Filter by:This is a follow-on study to the VELOUR trial (NCT00561470). The aim of this study is to acquire the archived colorectal cancer and metastasized tissue tumour blocks of patients who have participated in the VELOUR study. These samples will be analysed to find proteins or markers which represent how an individual may be responding to treatment. The identification of these markers may help provide personalised and more effective treatment programs for patients with similar conditions in the future.
This open-label, single arm, multicenter study will evaluate the resection rate in patients with colorectal cancer and previously untreated unresectable liver-only metastases after adding Avastin (bevacizumab) to 5-FU based doublet chemotherapy in the neoadjuvant setting. Patients will receive standard 5-FU based chemotherapy plus Avastin 5 mg/kg every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively unless they experience progressive disease or unacceptable toxicity.
Medical and Scientific Background: Colorectal cancers (CRC) are the leading cancers in both genders. This cancer is of prognostic severity. The prognosis of this cancer has not been significantly improved. The treatment of colonic cancer is primarily based on surgery. Adjuvant chemotherapy is proposed for metastatic cancers (stages III and IV). However nearly 30% of patients with localized cancer (stage II) will present a recurrence. Despite intense research efforts, no markers of sufficient prognostic value (independent of TNM) are available to identify this group of patients and justify intensified therapy. The natural history of cancer involves interactions between the tumor and the immune system of the host. The immune infiltration at the tumor site may be indicative of host response. We showed that the density of intratumor memory T cells (CD45RO) and cytotoxic T cells (CD8) in tumor regions (the core and the invasive margin) influenced the occurrence of early events of metastasis (tumor emboli) and was strongly associated with prognosis of patients with CRC (Pagès et al, NEJM-2005). This immune criterion was a better predictor of survival than the "gold standard" histoprognostic data of tumor invasion (T stage and N) and allowed to identify a group of patients at high risk of recurrence (*2). The availability of this immune criterion in clinical practice could improve the prognostic assessment of patients and better guide the therapeutic. A dedicated platform has been implemented in our hospital to speed up the transfer of this immune investigation into the clinic. The investigation takes into account the density of immune cell populations in tumor regions (the core and the invasive front of the tumor). This methodology has been validated for the markers CD45RO, CD3 and CD8 and leads to the creation of an immune score ("immunoscore" ranging from IO to I4). We validated the prognostic impact of the immunoscore in a retrospective series of 250 colorectal cancers. The main objective of this multicentric prospective clinical study is to assess in clinical practice the "immunoscore" and measure its prognostic value. The cohort study will include 400 patients with CRC stage I to IV (6 centers for inclusion; Paris-HEGP, Dijon, Bobigny-Avicenne, Besancon, Poitiers, Rouen). Two years of inclusion and a follow-up of 3 years for each patient will be performed (co-financing for data collection during the 4th and 5th year planned). For each patient, the pathologist of the center will send to the immunomonitoring platform of HEGP tissue sections from a paraffin block containing the tumor regions. The investigations will combine a step of immunostaining for CD3, CD8, and CD45RO (Ventana automate) markers, high-resolution scanning of the stained slides and quantification of digital images by an imaging module developed by our group from the program of Developer XD of Définiens company. The immunoscore will be calculated and the score will be correlated to the clinical data for the relapse and the survival. The secondary objective of this program is to evaluate the prognostic performance of the immune infiltrate on the biopsies performed for diagnostic purposes. This study will be conducted on patients of the cohort whose biopsies were performed in the same hospital than surgery and whose samples are available in pathology laboratories involved (representing 50% of cases). For the same patients will be conducted a genetic investigation of the tumor to assess the MSI status, the presence of a K-Ras and BRAF mutations. This investigation will be performed on tumor sections from the same tumor block selected for the immunohistochemical analyses. The sections will be processed by the Department of Biology, Hôpital Européen Georges Pompidou. The prognostic performance of the immune investigations performed on tumor sections and biopsies will be compared to that of genetic features of the tumor. Finally, a questionnaire will be sent every six months along the monitoring of the patients to obtain information concerning (i) the emergence of an immune disorder (such as allergy, autoimmunity, inflammatory process) and (ii) the psychological status of the patients. The potential impact of such parameters during the course of the disease on the prediction of the relapse and survival obtained with the immunoscore performed at the time of surgery will be evaluated. Expected results : This prospective study is an indispensable step for the clinical validation of the prognostic value of the immunoscore. The secondary objectives should help to precise the benefit of a concomitant analysis of the biopsy, the genetic features of the tumor. The questionnaire should help to identify the clinical parameters to track along the monitoring
Background: - Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the DNA of growing cancer cells. It is most often used with other chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They want to see if the drugs are a safe and effective treatment for advanced solid tumors or colorectal cancer that has not responded to other treatments. Objectives: - To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid tumors or colorectal cancer. Eligibility: - Individuals at least 18 years of age who have solid tumors or colorectal cancer that has not responded to other treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected as well before and after treatment. Imaging studies will also be performed. - Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the first cycle, they will also have ISIS 183750 on days 3 and 5. - Participants will take irinotecan every second week, beginning on day 15 of the first cycle. - Treatment will be monitored with frequent blood tests and imaging studies. - Treatment will continue as long as the cancer does not grow and the side effects are not severe.
This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells
The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.
This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.
The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.
The Norwegian government has funded a pilot study of a national colorectal cancer screening programme. This implies initiation of a screening pilot in the catchment area for two hospitals in Norway. The target population is average risk men and women at age 50-74 years. The programme is designed as a comparative effectiveness programme evaluating acceptance and test performance for two screening methods - fecal occult blood testing (FOBT) and flexible sigmoidoscopy (FS). This protocol describes the main methodological issues, necessary resources and the expected effects.
The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution. The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.