Gynaecology Cancer – Our Trials

Our Trials

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This is a prospective randomised, double-blind, comparative multicentre phase II trial in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who develop asymptomatic relapse as confirmed by CA-125 following first line treatment, comparing TroVax® to Placebo. Patients who are confirmed to have complete remission after 2nd line chemotherapy and develop asymptomatic relapse can also be entered into the trial.

This trial will enrol a maximum of 100 subjects in order to achieve 84 evaluable patients, who have developed asymptomatic relapse as defined by rising CA-125.

After signing the trial consent form and meeting the baseline enrolment criteria, 50 subjects will be recruited to the TroVax® and 50 subjects to the Placebo arm. The randomisation will be stratified to ensure approximately equal representation of the two treatment arms within subjects with either:

 

  • Radiologically assessable disease: None vs any

 

  • Relapse status at trial baseline: first relapse vs second relapse

 

  • Histological subtype

 

  • Site

 

Treatment will be administered on an outpatient basis.

 

 

Phase Ia:

Determine the maximally-tolerated dose (MTD) and/or the dose of ColoAd1 recommended for further studies when administered weekly by Intraperitoneal (IP) injection. The MTD is the highest dose of the drug which does not cause unacceptable side effects.

 

Phase Ib:

Determine the MTD and/or the dose of ColoAd1 recommended for further studies when administered by IP injection in combination with intravenous paclitaxel.

 

Phase II:

Evaluate Progression Free Survival (PFS) of ColoAd1 (using RECIST v1.1 guidelines) when administered by IP injection in combination with intravenous paclitaxel. RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.

 

The dosing days for the study drug will be administered at the Surrey CRC which is covered by having an SLA in place.

 

The intraperitoneal drain will be fitted and taken out by the Radiologist at RSCH.

 

The drains have to be a specific brand made by Rocket Medical in order to meet the compliance requirements for the virus

This study will focus on patients with previously untreated epithelial ovarian cancer, who are > 18 years and meed the inclusion criteria.

 

This study consists of 2 phases, a chemotherapy phase and a maintenance phase. In chemotherapy phase, patients will receive carboplatin-packutaxel alone (Arm A+B) or in combination with avelumab (Arm C) The chemotherapy phase may last a maximum of 6 cycles (18 weeks) and the maintenance phase is limited to 24 months with avelumab treatment or observation only.

 

Patients will be randomly assigned to a treatment arm by a computor system and treatment will be given by means of intravenous infusion (IV). Arm A+B in the Chemotherapy phase will be blinded to prevent, results being influenced unfairly. Arms A+B will be unblinded once the maintenance phase starts.

 

Patients would need to provide an archived tumour biospecimen, and need to provide a fresh tumour sample during the study.

 

Randomisation group:

 

Arm A: platinum-based chemotherapy alone followed by observation

Arm B: platinum-based chemotherapy alone followed by avelumab maintenance

ARM C: avelumab in combination with platinum-based chemotherapy followed by avelumab maintence.

 

+ 950 women across 200 different research sites in 28 countries is expected to take part.

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.

This research is about measuring the impact of cancer and its treatment on patients and their informal caregivers (e.g. spouse, partner, family member, close friend). Having cancer can affect many aspects of life such as finances, work status and patients’ own caring roles with family or friends, which are important to understand but are not well captured by existing measures.
In studies 1-3 of PROACT we developed and evaluated two questionnaires measuring impact on caregiving and other responsibilities and lifestyle disruption for patients and caregivers. We developed the questionnaires through qualitative interview studies and through collaboration with advisors with lived experience of cancer or caring for someone with cancer. We then conducted some research to determine the reliability and validity of the new measures.
These comparisons are important to ensure that when health care professionals and researchers use our questionnaires, they can be confident that they are measuring wellbeing and impact with a reliable measure. Both
questionnaires performed well in this initial evaluation. In this fourth study we wish to repeat the evaluation with a new group of patients and caregivers. We will expand our inclusion criteria to include different types and stages of cancer. We will use the same methodology as study 3 and invite participants to complete the new PROACT measures three times over two months, along with other quality of life questionnaires at two of these time points. This enables us to see how our new measures perform over time; whether they are reliable if completed twice close together and whether they are able to detect change in wellbeing if completed two months apart in participants whose situations are changing. This next stage in validation is essential to ensure that the questionnaires are suitable for use in future research and practice across different types of cancer.

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