Our Trials

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Ovarian cancer is cancer of the ovary. Chemotherapy for ovarian cancer usually consists of a platinum compound and a taxane with or without bevacizumab. Although the tumours are initially chemo-sensitive, up to 80% of patients relapse and only 46% of patients survive 5 years from the time of diagnosis.

Therapy at the time of recurrence depends on the time elapsed since completing initial platinum-based chemotherapy: Platinum-sensitive patients relapse more than 6 months after platinum-based treatment whereas
platinum-resistant patients relapsed within 6 months. Platinum-refractory disease patients progress during or within 4 weeks of the last dose of initial platinum-based chemotherapy.

There is not a clear standard of care for platinum-resistant or platinum-refractory disease with treatments varying by centre and geography and patients ultimately relapsing. New treatments are needed for platinum resistant patients who have failed or exhausted standard treatment options.
Prexasertib has been evaluated as a treatment for patients with advanced cancers and may be beneficial both as a single treatment and in combination with other DNA-damaging agents, targeted agents or radiation.

Study I4D-MC-JTJN is a multicentre, nonrandomized, parallel cohort Phase 2 trial of prexasertib. This study is being conducted to find out if prexasertib can help patients with ovarian cancer and to monitor any side effects patients may
have when they take prexasertib.

Uterine Cancer continues to be the fourth most common cancer in women in Europe and its incidence is rising to epidemic proportions. Over 94% of these cases are endometrial cancer. Despite this, there is no known peripheral biomarker available to aid diagnosis or prognosis. This study is aimed at looking at the immunological basis of endometrial cancer and at identifying biomarkers related to diagnosis and prognosis. Any woman attending the hospital with abnormal vaginal bleeding under the two-week rule pathway will be included in the study. Consent will be sought to obtain 30mls (2 1/2 tablespoons) of venous blood and a urine sample within the clinic setting. We will also take consent to have access to frozen tissue (taken within clinic or after surgery, when clinically indicated) after it has been analysed and reported for diagnostic purposes. In addition, as long as the pathologist is happy, a fresh tumour tissue will be obtained for analysis in suspected endometrial cancer patients only with prior patient consent. These biological samples will be analysed to look for various immunological molecules which play a role in both suppression and regulation of the immune environment in endometrial cancer.

We will also obtain blood samples from patients undergoing chemotherapy for advanced stage endometrial cancer to see if the markers can be used to assess response to treatment. We will also obtain 15 archival tissue blocks (5 normal, 5 endometrial hyperplasia and 5 endometrial cancer) to serve
as a control. This will be anonymised tissue and there will be no link to patients data. The aim would be to define and ultimately target the immunosupressive environment in endometrial cancer in order to develop novel immune related therapies and diagnostic tools.

This is a prospective study into women with cervical cancer which is localised to the pelvis. The majority of these patients will be treated with a combination of chemotherapy and radiotherapy followed by internal radiotherapy called brachytherapy. Patients who consent to participate in this study will be asked to have an additional biopsy, blood test and urine sample taken prior to any treatment starting and then again at each of the 3 brachytherapy sessions that they have. These biopies will be used in the laboratory to identify any changes in gene or protein expression throughout the course of treatment or changes in the surrounding tumour microenvironment. This will enable us to find out more information as to why some patients with cervical cancer completely respond to chemoradiotherapy and others either have residual disease left at the end of treatment or relapse after treatment. Hopefully this will then allow us to identify targets for future treatment escalated either with the addition of other drugs or with increased radiotherapy dose. The treatment pathway in the study will not be altered by this trial.

 

In addition to the laboratory aspect of this study, we also want to investigate whether new ways of analysing imaging during the course of radiotherapy can also help to identify patients who are more resistant to treatment. This will use the MRI and CT scans that patients routinely have during their treatment and will use a computer programme to perform Texture Analysis (TA). This has already shown to correlate with survival in patients with lung cancer and therefore we would like to see if it provides prognostic information in cervical cancer.

In patients with suspected Ovarian Cancer (OC), current guidelines recommend that a CT scan is performed in order to inform decisions as to what stage the cancer is at, and if the patient should have up-front surgery. Recent developments in MRI imaging have let to a new MRRI technique called multiparametric MRI (mpMRI), which has the potential to provide additional information that may influence decisions about how the patient should be treated. The aim of this study is to compare the staging of cancer and treatment plans for patients with suspected or confirmed OC, based upon findings from a CT alone, an mpMRI alone or a combination of CT and mpMRI.

645 women with suspected or confirmed OC will be recruited onto the study and will undergo an mpMRI in addition to the standard of care CT. The MDT (the medical team who make decisions about a patients care) will then determine the stage and treatment plan for the patient based on the CT alone. Any critical findings from the mpMRI will be revealed to the MDT after they have made an initial decision; the patient will then progress with treatment, as decided. A series of theoretical staging decisions and treatment plans will also be produced by the local team  and two external MDT’s . 6 months after entry onto the study, the local MDT will conduct a final case review. All available information will be reviewed and the correct stage and treatment plan for that particular patient will be determined.

During the study, patients will only attend one extra appointment for the mpMRI, all other data will be provided by their medical records and the MDTs. Participating patients will also be given the option to donate tissue samples, which would be obtained during surgery.

The aim of this study is to determine whether elemental diet (a type of drink that contains an elemental protein source known as amino acids) can be tolerated by patients with inoperable bowel blockage who can no longer eat and are only able to swallow small amount of fluid. The objective is to find out whether elemental diet (ED) can be used as an acceptable nutrition and whether it improves the quality of life.

Bowel blockage is a common complication in patients with ovarian cancer. Unfortunately when the cancer is advanced, this blockage can occur in many parts of the bowel therefore surgery is not possible. Every year in the UK there are around 7000 new cases of ovarian cancer and a very large proportion of patients develop bowel blockage, some publications report the rate as high as 50%. One way to feed patients with bowel blockage is through the veins; this is known as parenteral nutrition (PN) however PN is rarely used in the UK. Patients with malignant bowel blockage are often able to swallow small amounts of liquid but if they have no PN that are only able to survive for 2-3 weeks and the psychological as well as physical impact on patients and the family are very distressing. ED is a type of drink which contains an elemental protein source known as amino acids. ED drinks are almost totally absorbed in the upper part of the bowel and therefore could be absorbed even in patients who have bowel blockage which usually develops lower down in the gut. If this study is successful and proves that ED can be tolerated and provide nutrition to patients with inoperable bowel blockage it will be a big step towards improving the quality of life at the final stage of cancer.

Ovarian cancer is the fifth commonest cancer in UK and represents the commonest cause of death from gynaecologic malignancy and the fourth commonest cause of death from cancer in women. The initial benefit from chemotherapy is usually high for those women with the commonest type of ovarian cancer, but around 20% of women will develop recurrent cancer within 6 months of previous therapy. Ultimately patients with relapsed ovarian cancer will develop disease that becomes resistant to standard therapy and this group are described as having platinum-resistant disease and will have a poor response to subsequent treatments. Extensive research in the mechanism of resistance to platinum agents in the treatment of ovarian cancer so far has not produced any results in terms of improved responses and longer survival. Further experimental work and clinical trials with novel agents are therefore highly justified and address an unmet need. In such a patient population it is important to determine if current targeted treatments, offer an efficacious alternative to chemotherapy in an effort to improve survival and reduce toxicity.

www.HORIZONS-HUB.ac.uk

HORIZONS is a cohort study to explore recovery of health and well-being in adults diagnosed with cancer. Experiences and outcomes of cancer treatment and care are changing. A growing number of people are experiencing cancer not as a life-limiting disease, but as a life-changing and long-term condition. There is a growing imperative to understand the changing landscape of cancer and its consequences: as we do so, we will be better able to inform the design and delivery of cost effective interventions that make possible supported self-management, as well as service organization and delivery.
The key research questions are:
What impact does cancer and its treatment have on the lives of people diagnosed with cancer in the short, medium and long term?
What are the health outcomes, experiences and self-management activities over the life-course across different cancer types and who and what influence these?

HORIZONS is a series of prospective cohort studies of adults treated for non-metastatic cancer to capture their health outcomes and experiences from before they begin active treatment and regularly over their life-course. Our initial cancer cohorts will be breast cancer (diagnosed under age 50), non-Hodgkin lymphoma, and gynaecological cancers (ovarian, cervical, uterine). We will start recruitment with three pilot sites in NHS Trusts before rolling out full recruitment to approximately 50 NHS secondary care Trusts. Questionnaires will be completed before treatment (baseline), and followed up at regular intervals.

We will maintain and develop HORIZONS as a national and international resource to explore consequences of different cancer diagnoses and treatments from the individual perspective across the life-course.

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