Our Trials

rs154038_pg1_9383-hpr

The primary objective is to test the hypothesis that an association between common genetic

variations, reported by SNPs in relevant candidate genes, is associated with individual patient

variability in normal tissue radiation response and toxicity. To this end, the following normal

tissue toxicity scoring will be obtained from all patients:

  • LENT SOMA score

• Venous blood sample for SNP analysis.

A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab

Patients who have had radiotherapy to the head and neck region often have problems with swallowing or mouth opening. These problems may make it difficult to eat certain foods. Some patients are unable to eat enough and have to be fed through a tube. High doses of radiation can also decrease the blood supply to the jawbone. If this happens, the bone gets less oxygen than it needs, which may result in the death of bone tissue. This relatively rare condition is called osteoradionecrosis or ORN. All of these problems can have a negative impact on patients’ quality of life.

 

Research suggests that one or more genes may be linked to the risk of post-radiation complications in the head and neck. We have already studied one gene and found that patients with one variation of the gene had an increased risk of ORN.

 

In this study we want to test a much larger collection of genes. We want to find out whether we can predict swallowing and mouth opening problems.

 

DNA is a chemical that contains the genetic instructions needed for a plant or animal to develop, survive and reproduce. DNA provides a unique genetic fingerprint for each person. Nearly every cell in a person’s body has the same DNA. Genetic tests are done using DNA that has been extracted from a sample of blood or saliva. The tests allow researchers to see which genes are more frequently present amongst those patients with severe complications and/or which genes are present amongst patients with fewer problems.

 

We will compare the genes from 2 groups of patients:

 

  1. 100 patients with few problems – the control group
  2. 100 patients who have severe complications – the radiosensitive group
Thyroid cancer is the most common endocrine cancer, and while radioactive iodine therapy is an effective treatment for many patients, some patients will develop a thyroid cancer that does not take up iodine (iodinerefractory  disease).

This condition carries a much poorer prognosis with few 10 year survivors.

While some multitarget tyrosine kinase inhibitors have proved effective in reducing the rate of progression in suchiodinerefractorytumours, these drugs must be taken continuously to provide benefit, and these treatment regimenshave significant and unpleasant side effect.

 

Selumetinib, a MEK inhibitor, has been shown in a previous pilot study to be able to induce iodine uptake in previouslyiodine refractory thyroid cancers following a short, 4 week, course of treatment

This study is designed to determine the proportion of patients in which treatment with Selumetinib increases theamount of iodine taken up by the previously iodinerefractorythyroid cancers following a short course (4 weeks) of the

drug. If significant increase in iodine uptake is seen, patients will receive further radioactive iodine therapy. Patients will then be followed up to determine whether this strategy impacts progression free survival.

Recently published European guidance recommends the evaluation of the radiation dose to the bone marrow in patients undergoing radioiodine therapy for thyroid cancer. The methods described in these guidelines require serial blood samples to be taken from the patient, followed by a sophisticated analysis to determine the radiation dose. However, radiation risk assessments carried out locally have indicated that a relatively high radiation exposure will be received by the operator taking the blood samples, which may prohibit this procedure being carried out routinely in our clinic.

The radiation dose to the operator will be lowered if the duration of the blood sampling procedure were reduced. We hypothesize that the use of a lancet and pipette to collect blood from the finger tip will greatly reduce the time spent in proximity to the patient, significantly reducing the operator exposure and allowing this procedure to be performed routinely. The proposed method is also less invasive for the patient compared to the intravenous sampling recommended in the guidelines. A proof-of-principal pilot project using radioiodine diluted to the expected concentration in blood has indicated that using very small volumes of blood (such as from a lancet) does not compromise the accuracy of the dosimetry measurement when compared to large-volume standard blood samples.

Our primary aim is to investigate whether sampling a small volume of blood using a lancet and pipette can replace standard intravenous blood samples for bone marrow dosimetry in patients undergoing radioiodine treatment for thyroid cancer. Statistical tests will determine whether there is a significant difference between the doses calculated using each blood sampling method. In addition, we will measure the radiation exposure received by the operator during each procedure using Electronic Portable Dosimeters. The results of these measurements will be used to quantify the reduction in operator radiation exposure afforded by the new technique.

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