PETACC6

PETACC-6 aims to investigate if using a combination of capecitabine with oxaliplatin as chemotherapy in the pre- and post-operative treatment setting reduces the risk of recurrence or death in patients with locally advanced rectal cancer.

The five–year survival rate for locally advanced rectal cancer is less than 70%.  PETACC-6 is part of an international study led by the European Organisation for the Research and Treatment of Cancer. The aim of the trial is to test whether adding the new chemotherapy drug oxaliplatin to pre-operative standard chemotherapy and radiotherapy – and post-operative standard chemotherapy can improve disease-free survival for patients with locally advanced rectal cancer.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Aim

PETACC-6 aims to investigate if a treatment approach using a combination of capecitabine with oxaliplatin as chemotherapy in the pre- and post-operative treatment setting reduces the risk of recurrence or death in patients with locally advanced rectal cancer.

Summary

The five–year survival rate for locally advanced rectal cancer is less than 70%.

A combination chemotherapy treatment plan that includes the chemotherapy drugs capecitabine and oxaliplatin has been proven to have a beneficial effect in advanced colorectal cancer. Previous studies have also identified capecitabine to be a less toxic option. Therefore, a combination chemotherapy regimen – with capecitabine and oxaliplatin – instead of a treatment using a single drug may improve survival rates in rectal cancer.

PETACC-6 is part of an international study led by the European Organisation for the Research and Treatment of Cancer. The aim of the trial is to test whether adding the new chemotherapy drug oxaliplatin to pre-operative standard chemotherapy and radiotherapy – and post-operative standard chemotherapy can improve disease-free survival for patients with locally advanced rectal cancer.

The study is currently in the follow up stage with final analysis of data gathered during the study being undertaken.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Protocol Title

Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin versus capecitabine alone in locally advanced rectal cancer.

Publication Reference

Gormly KL, Coscia C, Wells T, Tebbutt N, Harvey JA, Wilson K, Schmoll HJ, Price T. MRI rectal cancer in Australia and New Zealand: an audit from the PETACC-6 trial. Journal of Medical Imaging and Radiation Oncology 2016; 60(5): 607–615.

Conference Presentation Reference

  1. Price T, Martyn J, Gill R, Hruby G, Gormly K, Harvey J, Ng S, Tebbutt N. PETACC-6: preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer. Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting; 9–11 Nov 2010; Melbourne. Asia-Pacific Journal of Clinical Oncology 2010; 6(suppl 3): 180. Abstract 284.
  2. Schmoll H, Haustermanns K, Price TJ, Nordlinger B, Hofheinz R, Daisne J, Janssens JF, Brenner B, Schmidt P, Reinel H, Hollerbach S, Caca K, Fauth FW, Hannig CV, Zalcberg J, Tebbutt NC, Mauer M, Messina CG, Lutz M, Van Cutsem E. Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine ±oxaliplatin in locally advanced rectal cancer: interim analysis for disease-free survival of PETACC 6. European Society for Medical Oncology Congress; 26–30 Sep 2014; Madrid.
  3. Schmoll HJ, Haustermans K, Price TJ, Nordlinger B, Hofheinz R, Daisne JF, Janssens J, Brenner B, Schmidt P, Reinel H, Hollerbach S, Caca K, Fauth FWB, Hannig C, Zalcberg JR, Tebbutt NC, Mauer ME, Messina CGM, Lutz MP, Van Cutsem E. Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin versus capecitabine alone in locally advanced rectal cancer: disease-free survival results at interim analysis. American Society of Clinical Oncology 50th Annual Meeting; 30 May–3 Jun 2014; Chicago.
  4. Schmoll H, Haustermans K, Price T, Nordlinger B, Hofheinz R, Daisne J, Janssens J, Brenner B, Schmidt P, Reinel H, Hollerbach S, Caca K, Fauth F, Hannig C, Zalcberg J, Tebbutt N, Mauer M, Messina C, Lutz M, Van Cutsem E, for the EORTC GITCG A, AGITG, EORTC ROG, BGDO, FFCD,. Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin versus capecitabine alone in locally advanced rectal cancer: First results of the PETACC-6 randomized phase III trial. American Society of Clinical Oncology Annual Meeting; 31 May–4 Jun 2013; Chicago. Journal of Clinical Oncology; 31 (suppl.): 3531.
  5. Schmoll HJ, Price T, Haustermanns K, Nordlinger B, Hofheinz RD, Daisne JF, Janssens J, Schmidt P, Reinel H, van Cutsem E, EORTC GITCG, AIO, AGITG, EORTC ROG, BGDO, FFCD. Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer: response to the local treatment after chemoradiation and surgery as secondary endpoint. Deutsche, Österreichische und Schweizerische Gesellschaften für Hämatologie und Onkologie; 18–22 Oct 2013; Vienna.

Aim

PETACC-6 aims to investigate if addition of oxaliplatin to pre-operative capecitabine chemoradiotherapy and post-operative capecitabine chemotherapy improves disease free survival in patients with locally advanced rectal cancer.

Background

For locally advanced rectal cancer the 5-year overall survival rate remains below 70%. Even with improved rates of local control in rectal cancer, no recent improvements have been seen for distant recurrence or overall survival. It is thought that a combination chemotherapy regimen – with capecitabine and oxaliplatin – instead of a single agent regimen may improve the overall outcome due to its potentially higher impact on micro metastases, as it has already been proven to do so in stage III colorectal cancer.

PETACC-6 is part of an international study led by the European Organisation for the Research and Treatment of Cancer. The aim of the trial is to test whether adding the new chemotherapy drug oxaliplatin to pre-operative chemo-radiotherapy and post-operative chemotherapy can reduce the risk of recurrence or death for patients with locally advanced rectal cancer.

Capecitabine was chosen as a substitute for IV 5-FU for all treatment arms of the study as it is already proven that 5-FU and capecitabine show similar results in terms of complete response and disease free survival rates for stage III colorectal cancer. Capecitabine, however, offers reduced toxicity. The addition of oxaliplatin to capecitabine has shown to be effective and safe in phase II trials of preoperative chemoradiotherapy and in large phase III trials for stage II/III colorectal cancer.

The study is currently in the follow up stage. Analysis of data was undertaken early in 2016 and five-year follow up data has been collected until mid-June 2017 when final analysis will be undertaken.

Clinical Trial Design

The PETACC-6 study is an open-label, randomised, multi-national, two-arm phase III study. Eligible patients were randomised to one of two treatment groups.

Participants in the control group received the chemotherapy drug capecitabine with radiotherapy before surgery, followed by capecitabine after surgery. Participants in the investigational arm received capecitabine with oxaliplatin and radiotherapy before surgery, followed by capecitabine and oxaliplatin after surgery.

All participants in this trial are being followed for 5 years post treatment.

Contact Email

petacc6@ctc.usyd.edu.au

Principal Investigator

Professor Tim Price (Queen Elizabeth Hospital, Woodville SA)

More Information

Visit ANZTCR for more detailed information on inclusion/exclusion criteria and eligibility.

Funding

Cancer Australia