Our Trials

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The Study 15 trial is a phase II trial to examine whether the addition of hydroxychooroquine (HCQ) to chemotherapy can improve progression free survival in patients with small cell lung cancer (SCLC).

Lung cancer, the leading cause of cancer-related death, accounting for nearly 1.4 million deaths worldwide every year, and has an annual incidence of over 41,000 in the UK. 10-15% are SCLC, representing about 4500 new cases per annum in the UK. Compared with non-small cell lung cancer (NSCLC), patient with SCLC are more responsive to chemotherapy (with an objective response rate of about 70-80%) and radiation treatment but relapse quickly with treatment resistant disease. The survival rates are poor, with less than 10% of patients alive by 5 years. In a previous CR UK & UCL Cancer Trials Centre involving 724 patients, the median survival was 10.3 months. The standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.

There is increasing interest in targeting autophagy as a means of selectively killing cancer cells. Numerous pre-clinical studies have demonstrated that small molecule inhibitors of autophagy including chloroquine (CQ) and its analogue, hydroxychloroquine (HCQ), enhances the activity of a broad array of anticancer agents. These results have recently led to multiple clinical trials to evaluate autophagy inhibition in combination with conventional chemotherapy.More recently, CQ was found to have tumour vasculature normalising properties, thereby increasing platinum delivery to tumour tissue and improved chemosensitivity. The advantage of using HCQ instead of CQ is less cumulative retinal toxicity issue. Previous preclinical studies demonstrate that HCQ that etoposide are mutually antagonistic. Study 15 will combine HCQ with gemcitabine/carbopatin chemotherapy in the investigational arm to avoid the antagonistic interaction with etoposide. The control arm remains carboplatin/etoposide due to the fact that this remains the Standard of Care for patients at sites throughout the UK. We previously demonstrated carboplatin-gemcitibine is as effective as standard carbo/etoposide and associated with a better toxicity profile and cognitive function. The study 15 trial will therefore investigate whether the combination of HCQ with carboplatin-gemcitibine compared with standard chemotherapy confers additional survival benefit.

 

Each patient will be randomised between the control arm and the investigational arm. All eligible patients that consent to take part in the trial will be randomised onto the trial and will receive 4-6 cycles of chemotherapy, those randomised to the investigational arm will also receive HCQ alongside chemotherapy for up to 30 months. All patients will be followed up for 36 months after the last trial treatment is administered to the last patient or until death.

The trial will be undertaken throughout the UK in approximately 30 NHS sites. The target accrual is 112 patients. The trial is funded by the London Lung Cancer Group (LLCG), endorsed by Cancer Research UK and sponsored by University College London.

Lung Cancer is the second commonest malignancy diagnosed in men and women in the UK. It is the leading cause of cancer mortality worldwide. Unfortunately patients with lung cancer often have poor outcomes. It is known that non drug treatment in the form of early palliative care review for symptom control improves overall survival in lung cancer.

Many patients with lung cancer experience symptoms of fatigue, poor oral intake and weight loss. It is not clear how many patients diagnosed with lung cancer are malnourished (imbalance between calorie intake and consumption) have cachexia (loss of muscle mass, defined as >5% weight loss) or sarcopenia (loss of muscle mass and function) and how the inter relate.

This study aims to identify the proportion of patients who are malnourished/cachetic/sarcompenic before starting treatment for lung cancer. Whether being malnourished predicts outcome and whether early intervention can prevent further weight loss.

Metastatic spread of cancer from its primary site to distant organs is the commonest cause of death from cancer. The term oligometastases describes an intermediate metastatic state, in which cancer exists as a limited number of metastases at first, before cells acquire the ability to metastasise more widely. For the large majority of solid cancers,

once metastatic disease has been diagnosed the chances of cure are small. There are several situations where this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment is justified. SBRT is targeted radiotherapy which destroys

cancer cells in the area of the body it is aimed at however low dose radiation may be received by surrounding tissue.

It is difficult to quantify incidence of patients with multiple primary cancers developing at intervals that are representative of oligometastatic stage IV disease, (defined for the purposes of this trial as ≤ 3 metastatic sites).

However an increase in the use of surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis of patients with asymptomatic oligometastatic relapse becoming a more common clinical occurrence. The CORE study is a randomized controlled trial that will be conducted in patients with cancer in one of three primary sites where oligometastatic disease relapse is a common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The study will evaluate the use of SBRT in this patient population.

Eligible patients who consent to participate in this clinical trial will be randomized to receive standard care or standard care plus SBRT we hope to recruit approximately 206 patients to the study and the primary outcome measure is progression free survival.

A phase III, prospective, randomised, double-blind, multicentre study of the efficacy and safety of lanreotide autogel/depot 120mg plus best supportive care (BSC) vs. best supportive care for tumour control in subjects with well differentiated, metastatic and/or unresectable typical or atypical lung neuroendocrine tumours.

 

The purpose of this study is to assess the role of Lanreotide plus best supportive care (BSC) in the management of metastatic and/or unresectable, well differentiated, typical or atypical lung neuro-endocrine tumours (NET)

 

This study consists of the double blind phase and the open label extension phase.

Stereotactic Ablative Radiotherapy (SABR), is an emerging novel radiation technology. SABR is a specialised radiotherapy treatment planning technique resulting in a high dose to the target with steep dose gradients resulting in rapid dose fall off outside the target area. This results in high biologically effective dose (BED) while minimising the dose received by the normal tissues, and could potentially minimise the radiotherapy treatment toxicity and side effects.

 

The technique requires specialist positioning equipment and/or imaging (stereotaxis) to confirm correct targeting (accuracy) and it can be delivered using either standard linear accelerators or specially designed devices which are dedicated to delivering stereotactic treatments. Using a small number of fractions provides the opportunity for cost savings compared with conventional fractionation or surgical alternatives, and may free up capacity within NHS radiotherapy departments.

 

There is now evidence from multiple non-randomised retrospective studies demonstrating that SABR is associated with local control rates of ~90% and can be given with minimal toxicity. Some early findings suggest it may be possible to delay the need for systemic therapy and improve progression-free survival using SABR. Further data is required to

determine whether these benefits translate into an overall survival benefit.

The SARON trial is a phase III trial looking to see if adding radiotherapy (conventional, stereotactic radiotherapy and / or stereotactic radiosurgery (give to the brain)) to standard chemotherapy can improve overall survival in non-small cell lung cancer (NSCLC) patients with 13 metastases.

The target accrual is 340 patients. The trial is funded by Cancer Research UK and sponsored by University College

London. The trial will be coordinated by the CR UK & UCL Cancer Trials Centre.

  • All patients in the trial will receive 2 cycles of chemotherapy.
  • After two cycles, patients will be assessed for progression. Those that have not progressed will be randomised.
  • Patients randomised to the control group (chemotherapy only) will receive 2 more cycles of chemotherapy.
  • Patients randomised to the investigational group (chemotherapy plus radiotherapy group) will receive 2 more cycles of chemotherapy followed by radiotherapy.
  • All patients will be followed up for 3 years after completing trial treatment or until death.

A safety sub-study will look at the first 20 patient receiving stereotactic radiotherapy to their chest to assess the level of lung inflammation within the first 3 months after the end of treatment.

A feasibility sub-study will make an assessment after the first 50 patients have been randomised. This will review the practicality of achieving recruitment targets, assess the logistics of delivering the radiotherapy treatment, and the potential for patients seeking stereotactic radiotherapy off study if randomised to the control group.

Treatment of patients with advanced non-small cell lung cancer (NSCLC) and EGFR (epidermal growth factor) mutations or ALK (anaplastic lymphoma kinase) rearrangements has developed significantly with tyrosine kinase inhibitor (TKI) therapies. Higher response rates and progression free survival (PFS) are seen compared to comparator chemotherapy; however disease progression will ultimately occur in all patients due to acquired resistance to TKI.

 

HALT is a phase II, randomised multi-centre study with integrated seamless continuation to phase III trial following acceptable safety and feasibility assessment. HALT aims to recruit 110 patients with mutation positive advanced NSCLC with OPD following initial response to TKI. Patients will continue on background TKI and will be randomisation (2:1) to receive SBRT or not. Patients will be seen 8 weeks post randomisation, then 3 monthly in line with routine care. Tumour imaging and toxicity assessment will be 3 monthly until disease progression. Quality of Life will be assessed at baseline, 8 weeks and at the first 3 month visit. Research bloods will be collected a baseline, after the first SBRT fraction (treatment group), 8 weeks and 3 monthly until change in systemic therapy.

This is a clinical research study to find out if the drug, canakinumab, is safe and effective in preventing the reappearance of cancer in people who have had non-small cell lung cancer. Patients will already have had an operation to remove the primary cancer, followed by chemotherapy and radiation therapy (if applicable) depending on the severity of their disease at the time of original diagnosis.

Canakinumab is an antibody (a specific type of protein). It is able to bind to a naturally occurring agent of the inflammatory system called interleukin-1 beta (IL-1β). It works to lessen inflammation by blocking IL-1β activity. By blocking inflammation this may work against cancer growth. It is administered by the study team as an injection in the upper arm, upper leg or skin on the stomach. This is the first time it will be studied on its effectiveness and safety in cancer. It is approved for use in the UK for treatment of some inflammatory conditions and over 15,000 patients have received it to-date for these.

Eligible patients will have an equal chance of receiving either canakinumab or a placebo (a dummy drug substitute with no active ingredient). Study drug will be given every 3 weeks for a total of 18 cycles of treatment followed by an end of treatment visit. There are then 5 safety follow-up visits (every 28 days for 130 days after last study drug dose). Patients will be monitored for the reappearance of cancer for approximately 5 years after first dose of study drug at clinic visits every 6 months for years 2 and 3 and annually for years 4 and 5. Clinical visits will involve blood and urine samples and questionnaires about quality of life. Some visits also include CT or MRI scans and an ECG.

Stereotactic Ablative Body Radiotherapy (SABR) is a specialist type of radiotherapy treatment, commissioned for patients with inoperable stage one non-small cell lung cancer. This is an aging patient group, with complex needs.

Around half of radiotherapy departments in England are commissioned to deliver this treatment, which results in many patients having to access treatment from a radiotherapy department which may not be local to them. This also requires integration of care and between the specialist radiotherapy department and the multidisciplinary team at the patient’s local hospital. Although the centralisation of services is designed to ensure fair and equitable access to a treatment that is thought to be more effective, it is not known how this centralisation of care is experienced by patients. Centralisation of specialist services has previously occurred in the NHS; stroke, neonatal and cardiac.

This is a single centre study and aims to explore patient’s experiences and perceptions of patient centred care when recieving SABR for primary lung cancer at a commissioned centre.

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