Our Trials

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The aim of this research study is to compare and evaluate two established treatments for oesophageal cancer in order to establish if one treatment is superior to the other. The research group believe it is not currently clear which regimen is of greatest benefit to patients. These 2 regimens have been tested in previous randomised trials (MAGIC & CROSS).

 

The 2 treatments are either chemotherapy before and after surgery, or chemotherapy with radiotherapy before surgery. Both treatments are standard and have been in use as treatments for oesophageal cancer for several years. 594 patients with oesophageal and oesophagogastric junction cancer will be randomly allocated to these 2 treatments. During the trial patients will have a variety of clinical assessments and will complete health-related questionnaires.

 

Following objectives are patient quality of life, complications and relief of swallowing problems.

This study will evaluate whether increasing the dose of radiotherapy and/or the addition of nelfinavir to the chemotherapy increases the progression free survival in patients with inoperable cancer of the pancreas that has not spread beyond the pancreas.

 

The study consists of 2 stages:

 

Stage 1 – to determine the safe, tolerable dose of nelfinavir to be administered alongside chemoradiotherapy. This will establish the dose of nelfinavir to be taken forward to stage 2.

 

This will identify an optimum dose of oral nelfinavir in comnbination with capecitabine during radiotherapy, following 4 cycles of GEMABX.

Endpoint – a safe and tolerable dose of nelfinavir to be administered alongside chemoradiotherapy.

Stage 2

1. Does increasing the radiotherapy does schedule improve the 12 months survival rate?

2. Does the addition of nelfinavir to CRT improve progression free survival?

All patients revieve three cycles of GEMABX. Those without progression disease will then be randomised to one of the following arms.

Arm A: Nelfinavir together with chemoradiotherapy

Arm B: Chemoradiotherapy (without nelfinavir)

Arm C: Nelfinavir together with chemoradiotherapy (but using a higher dose of radiotherapy) – this involves 2 more fractions

Arm D: Chemoradiotherapy without nelfinavir (but using a higher dose of radiotherapy) this involves 2 more fractions

Arm E: Chemotherapy alone

Patients not eligible for the study will be treated as per local standard but will be followed up on the study.

Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers

Advanced cancers of the stomach or oesophagus are normally treated with 2drug
or 3drug
combination
chemotherapy regimens. In patients with tumours that are negative for a protein called HER2,
the normal
management after completion of the chemotherapy is to proceed with regular followup
‘surveillance’ to monitor for any
signs of the cancer starting to regrow.
In patients with tumours that are positive for HER2,
the normal treatment after
completion of the chemotherapy is to proceed with an antibody drug called trastuzumab on its own and continue to
monitor for evidence of the cancer starting to regrow.
In both cases, the break from chemotherapy will usually allow
patients to recover from any treatment sideeffects.
Further chemotherapy may be given at the time of the cancer
starting to regrow.
However, there is interest in developing drugs which may be more tolerable than traditional chemotherapy, and which
could be administered during this surveillance period to try and prolong the length of time until the tumour starts to regrow.
Within the PLATFORM study, researchers are evaluating a number of different drugs which could be added in
this ‘maintenance’ setting to see whether any of them may improve disease control and the length of time that
somebody lives with advanced cancer of the stomach or oesophagus.

Add-Aspirin is a large clinical trial for people who have had treatment for breast, colorectal, gastro-oesophageal or prostate cancer. The aim of the trial is to find out whether taking aspirin regularly after treatment for early stage cancer stops or delays the cancer coming back.

Participants will self-administer 100mg aspirin once daily for 8 weeks. After 8 weeks, if taking regular aspirin does not cause any serious problems, participants will be randomly allocated to self-administer either a 300mg aspirin tablet, a 100mg aspirin tablet or a placebo tablet once daily for at least five years. Participants who are 75 years old or over will only be allocated to 100mg aspirin tablet daily or placebo tablets. To ensure the results of the trial are as reliable as possible, neither the participants, nor the clinicians will know which tablet participants are allocated to.

A programme of associated correlative science is planned incorporating both short and long term projects which will investigate key questions including@ determining the mechanism of action for an anti-cancer effect of aspirin; determining biomarkers that identify participants most likely to experience serous aspirin-related toxicity; determining the roles of genotypic and phenotypic difference in aspirin’s actions identifying individuals who will benefit most or least from aspirin and determining the mechanisms underlying potential non-cancer benefits of aspirin.

Cancers that occur at the junction between the oesophagus (gullet) and the stomach are called gastro oesophageal junction (GOJ) adenocarcinomas. They are 6 times more common than they were 30 years ago and have a very poor outcome (only 1 in 5 patients will survive five years). We have previously developed a new way of determining how advanced a patient’s GOJ adenocarcinoma is (what we call staging) using both the physical features determined by the radiology tests and the molecular features of the cancer. This system works significantly better than the existing way we stage these cancers. However this new system was developed using patients who had already had their surgery. We now want to test it on patients at the beginning of their treatment− or what we term prospectively.

The patients management will not differ from current practice but as well as looking at the features used for staging at the moment we will also record our new system in parallel. We will also test samples of the cancer, which are already routinely taken, for the molecular changes we think will predict survival. After this patients will undergo the standard treatment at each of the centres involved. It will then be possible to determine both how practical our new system is and how good it is at predicting survival. We will be running this prospective trial in multiple hospitals across the country to ensure that our system is broadly applicable.

If we can prove that our revised staging system, using both the physical features of the tumour and the molecular changes, can accurately predict outcome this will allow us to give far better information to our patients about their chance of a cure but also it will also allow treatments to be targeted at those who will benefit the most.

Oesophageal cancer is the sixth most common cause of cancer deaths in the world and is more prevalent in men than in women.

The majority of patients are diagnosed with advanced/metastatic cancer (cancer which has spread), and in this setting, response to chemotherapy is poor. Given the high incidence and mortality worldwide and lack of good
therapeutic options, oesophageal cancer patients represent a high unmet need for drug development.

This is a phase III, randomised, double blind, placebo controlled trial of a study drug pembrolizumab in combination with cisplatin and 5-fluorouracil compared to placebo (dummy drug) in combination with cisplatin and 5-fluorouracil as first-line treatment for oesophageal cancer.

The purpose of the trial is to evaluate how effective and safe pembrolizumab is in combination with chemotherapy compared with placebo and chemotherapy.

Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. Interaction between these ligands and the receptors present on the immune cells prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.

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