ROCOCO: Radiotherapy & olaparib for oesophageal carcinoma
Research type
Research Study
Full title
ROCOCO: Radiotherapy and Olaparib in COmbination for Carcinoma of the Oesophagus. A phase I study.
IRAS ID
72753
Contact name
Andrew Jackson
Sponsor organisation
The Christie NHS Foundation Trust
Eudract number
2011-002882-39
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
For patients with oesophagus cancer which has not spread (metastasised), surgery (radical oesophagectomy) is considered to try and effect a cure. For patients who are unsuitable for major surgery, but who still have disease which has not spread, treatment with chemotherapy and radiotherapy given at the same time (concurrent chemo-radiotherapy) is considered. Trials show that this can cure 25-30% of patients long term, which is a similar success rate to surgery. Radiotherapy or chemotherapy on their own do not result in long term cure.Concurrent chemo-radiotherapy can have serious side effects, and not all patients are well enough to have this treatment, particularly patients with heart or kidney problems.Olaparib is a drug given by mouth belonging to a family of drugs called PARP inhibitors. PARP is an enzyme found in all cells which repairs damage to the cell, specifically, damage to DNA, the cell's 'blueprint' molecule. Olaparib blocks the action of PARP, and has been used to treat certain cancers which are known to already have difficulties repairing their DNA.Radiotherapy works by damaging DNA, and it has been shown that PARP inhibitor drugs can increase the effect of radiotherapy by reducing the ability of cancer cells to repair their DNA damage, resulting in more cancer cells dying.In this study we will be using radiotherapy at the same time as olaparib to treat patients with oesophagus cancers which have not spread, but who are unsuitable for surgery/concurrent chemo-radiotherapy. In this phase 1 study, patients will have the same dose of radiotherapy, but successive groups will have a higher dose of drug. This will establish the highest dose that can be given safely with radiotherapy in this setting.Patients will be asked to have additional blood tests and a skin biopsy. This will help us understand how RT and olaparib work together.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
12/SC/0616
Date of REC Opinion
14 Feb 2013
REC opinion
Further Information Favourable Opinion