COPERNICUS
Research type
Research Study
Full title
A Phase II study of neoadjuvant chemotherapy given before SCPRT as treatment for patients with MRI-staged operable rectal cancer at high risk of metastatic relapse
IRAS ID
101400
Contact name
Simon Gollins
Contact email
Eudract number
2010-023083-40
Clinicaltrials.gov Identifier
Research summary
Of the 15,000 patients diagnosed with rectal cancer in the UK every year, around 4,800 will have disease that whilst suitable for surgical removal (resection) has a good chance of spreading to other parts of the body (metastasis). These patients would normally receive a short course of radiotherapy (SCPRT) one week before surgery and chemotherapy after surgery. However, despite postoperative chemotherapy approximately one third of such patients will relapse with metastatic disease within the first three years after surgery. In addition, patients do not tolerate chemotherapy well post-radiotherapy and surgery. If an element of chemotherapy can be delivered preoperatively then this might improve outcome by tackling the issue of micrometastatic disease at an earlier stage in the treatment paradigm and in addition be better tolerated than postoperative chemotherapy. COPERNICUS is a phase II trial that aims to see whether it is possible to give these patients chemotherapy prior to SCPRT and surgery. 62 patients recruited over a 2 year period, will all receive 4x14-day cycles of chemotherapy before SCPRT and surgery and 8x14-day cycles of chemotherapy after surgery. The success of the COPERNICUS trial will be measured by counting the number of patients who: (i) start chemotherapy and go on to have surgery, (ii) experience toxicities, (iii) have shrinkage of their tumour, (iv) remain free from cancer, (v) have local recurrence/distant spread of their cancer, (v) complete treatment, (vii) are still alive 12 months after enrolment and (vii) are successfully recruited. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment. If results suggest that that the COPERNICUS regimen is effective it will be taken forward and evaluated in a randomised Phase III setting.
REC name
Wales REC 3
REC reference
12/WA/0051
Date of REC Opinion
12 Mar 2012
REC opinion
Favourable Opinion