PETACC-6 (EORTC 40054-22062)v1.1

• Research type

  Research Study

• Full title

  Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

• IRAS ID

  13279

• Sponsor organisation

  EORTC - European Organisation for Research and Treatment of Cancer

• Eudract number

  2006-006532-21

• Clinicaltrials.gov Identifier

  00766155

• Research summary

  Patients with locally advanced rectal cancer (T3 or T4) have a high risk of local recurrence with surgery alone and pre-operative chemoradiotherapy or short course radiotherapy are standard throughout Europe.These patients have a 30-35% risk of developing metastatic disease and the rationale for this trial is to see whether the addition of oxaliplatin/capecitabine will reduce the risk of metastatic disease.Two phase III studies in Stage II/III colon cancer have shown that combination chemotherapy with a 5FU/Oxaliplatin regimen improved the 3-year disease-free survival rate. This combination should also be investigated in rectal cancer. Moreover, in all settings, capecitabine has been shown to be a viable substitute for IV 5-FU. It is as safe and as effective as 5-FU and has lower rates of potentially dangerous grade 3/4 diarrhoea and neutropenia. This is an open label, randomised, multi-centre, 2-arm phase III trial with patients randomised to either the Control Arm or the Investigational Arm:CONTROL ARM: capecitabine with radiotherapy before surgery, followed by capecitabine after surgery.INVESTIGATIONAL ARM: capecitabine with oxaliplatin and radiotherapy before surgery, followed by capecitabine and oxaliplatin after surgery.Ancillary studies will be conducted with the aim of predicting the risk of peri-operative complications in elderly patients. In the UK, the translational research part of the study will not be performed at this time.A total of 1090 patients will be recruited throughout the EU. The EORTC (European Organisation for Research and Treatment of Cancer) which is a non-profit research organisation, is the legal sponsor of the trial and has financial support from F.Hoffman-La Roche Ltd and Sanofi-Aventis.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/55

• Date of REC Opinion

  25 Jun 2009

• REC opinion

  Favourable Opinion