BACCHUS

• Research type

  Research Study

• Full title

  Bevacizumab And Combination Chemotherapy in rectal cancer Until Surgery: A Phase II, Multicentre, Open-label, Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients with MRI defined High-Risk Cancer of the Rectum

• IRAS ID

  86480

• Contact name

  Rob Glynne-Jones

• Sponsor organisation

  University College London

• Eudract number

  2010-022754-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to look at two different combinations of anticancer drugs to see how effective they are at shrinking cancer and preventing it from coming back after surgery. Patients with locally advanced rectal cancer are sometimes treated with radiotherapy, with or without chemotherapy, before having surgery. This decreases the size of the main tumour which makes it easier for the surgeons to remove all of it. Radiotherapy treats only the main tumour in the rectum. This means that if tiny deposits of cancer have spread to other parts of the body (metastases), these could continue to grow. Giving chemotherapy and radiotherapy together (chemoradiotherapy) can treat both the main tumour and metastases. However, due to the side-effects, the dose of chemotherapy is lower when given in combination with radiotherapy than if chemotherapy were given on its own. As a result, treatment of possible metastases may be compromised. If the risk of the main tumour coming back is quite small, then giving treatment that targets metastases should be the best option. This study looks at two well known combinations of chemotherapy drugs: FOLFOX (folinic acid, flurouracil, oxaliplatin) and FOLFOXIRI (folinic acid, flurouracil, oxaliplatin, irinotecan). Chemotherapy works by killing rapidly diving cells, such as cancer cells. In addition, the anticancer drug bevacizumab (BVZ) will be given with both the FOLFOX and FOLFOXIRI. Bevacizumab is an ??anti-angiogenesis? drug. It works by stopping tumours from making new blood vessels. Without new blood vessels, the cancer cells do not get the food and oxygen they need to survive and grow. Attacking the cancer by these two different ways may be more effective than chemotherapy alone. Sixty patients with rectal cancer will be enrolled in the trial. Patients will receive FOLFOX BVZ or FOLFOXIRI BVZ, with 30 patients being allocated to each of the two treatment groups. Before starting treatment, patients will have a PET scan which will provide information about the size of the tumour and how active the cancer cells in it are. The treatment for each patient will be randomly allocated. Both FOLFOX BVZ and FOLFOXIRI BVZ will be given by intravenous infusion in two weekly cycles. After the third cycle, the PET scan will be repeated. If the treatment is working, the cancer cells should be less active. If the PET scan shows that the treatment seems to be working, the patient will have another three cycles of treatment. Otherwise, they will stop trial treatment. Patients who have completed treatment will be assessed to see if they are suitable for surgery. Those that are will go on to have surgery. All patients will be followed up for three years. The results of this trial will provide information about how effective each of the treatments is, and about how tolerable they are. This will help to make decisions about whether these treatments should be tested in larger studies.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1158

• Date of REC Opinion

  22 Aug 2012

• REC opinion

  Further Information Favourable Opinion