View clinical trials related to Gastrointestinal Neoplasms.
Filter by:This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.
This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient refusal. Assessment of response will be confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks thereafter.
This study will test the impact of newly created and available symptom management patient education brochures on symptom burden [measured via the Edmonton Symptom Assessment System (ESAS)], health-related quality of life [measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. Symptom screening occurs at each visit as patients are required to fill out ESAS, that asks about their experience with the occurence and severity of symptoms. The intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. The brochures also provide information to patients about when and how to seek further help from their oncology team. The hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity It is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.
This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.
The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.
Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.
Acute post-operative pain causes not only discomfort for the patient, but delays recovery by increasing the morbidity of the circulatory system, respiratory system, and immune system, so pain control is one of the important objectives in peri-operative patient management. Patient controlled analgesia (PCA) is a piece of equipment for which the patient can personally control the administration of an analgesic. It is generally used in postoperative pain management because it is a method which can heighten patient satisfaction by reducing complications and obtaining the appropriate level of pain relief. Usually, it is designed to administer an analgesic at a steady speed, and the patient can administer additional medication by pressing a button when the pain is severe. Here, to prevent complications from excessive administration of an analgesic, repeated administration is not allowed within a certain time interval. The PCA equipment can be categorized as electronic and physical according to the force which operates the drug injection pump. Electronic equipment uses electrical energy to apply vermicular movement to the fluid tube to administer the analgesic. Physical equipment is disposable equipment designed to fill an elastomer reservoir bag expanding the material, and its elasticity returns to the original length used to administer the analgesic. The physical equipment is easy to carry and movement is comfortable because there is no need for additional electronic equipment or devices. There is also no need for special training to operate the equipment, and the action mechanism is simple so there is less opportunity for malfunction. The disposable physical equipment accounts for approximately 70% of the domestic market share and it is preferred over the electronic equipment. On the other hand, contrary to the electronic equipment, the physical PCA equipment has the disadvantage of not providing information regarding the history of the equipment's use. The early physical PCA equipment was very simple and only had the function of continually administering medication at a set speed. Hence, it was not sufficient to function as 'patient controlled' pain control equipment. Then, the function of an additional administration button was added so that the patient can personally decide whether to administer an additional amount of analgesic. At the same time, the physical PCA equipment has improved to prevent excessive administration by setting a lock-out time as a safety measure. The following development was Accufuser Selectuss®, where a function was added to select the administration speed from three options. In this way, the physical PCA equipment has continued to evolve in the direction of enhancing safety, convenience, and clinical effectiveness. The advantage of pain control using PCA equipment is that the patient can personally control additional the administration of an analgesic by pressing a button. In the case of existing or imported products, it is designed to administer a bolus by pressing the button, and the pressure presses the PVC bag filled with medication under the button to administer the bolus. Compared to the intravenous route, using an epidural as a PCA administration route has superior analgesic effect, so it can reduce the amount of opioid analgesic administered. On the other hand, the disadvantage is that it has to pass through a narrow and long epidural catheter to deliver the medication to the epidural space which has a relatively higher resistance. Woo Young Medical experimented with their own product Accufuser plus® (Woo Young Medical, Korea), and the results showed that the time taken to empty the bolus bag was approximately 40-80 seconds depending on the dosage. The pressure when a person presses the bolus button on the PCA equipment was repeatedly measured to obtain a mean value, and this pressure was constantly maintained by a machine to measure the time taken to empty the bolus bag. Clinically, it is not easy to continually press the button for 40-80 seconds, so it is difficult to exclude the possibility that the bolus was not administered properly. In addition, when excessive pressure is applied, there is the possibility that the bolus bag may burst. The domestically developed products and Accufuser Omnibus® (Woo Young Medical, Korea) was developed for the purpose of supplementing bolus failure which can occur when using epidural PCA. Within the bolus module, a second elastomeric balloon is installed behind the first bolus bag so the patient does not have to press the bolus button for a long time. Therefore, this research focused on the effectiveness and safety of the domestic product Accufuser Omnibus® (Woo Young Medical, Korea) regarding whether the bolus is sufficiently delivered when it is administered through the epidural route, and compared the results through a comparative clinical trial with imported physical PCA equipment (Infusor SV®, Baxter, USA).
The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol