EORTC 40983

Pre and post-operative chemotherapy with oxaliplatin 5-FU/LV versus surgery alone in resectable liver metastases from colorectal origin – phase III study.

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Trial Status

Completed

Cancer Type

Liver Cancer

Aim

Cancers from the colon or rectum often spread to the liver (metastases). Sometimes these cancers can be removed from the liver with an operation, but the cancer often comes back later (recurs). This trial will determine if adding chemotherapy for three months before and after surgery can improve the cure and recurrence rates.

Summary

Surviving patients are now on yearly follow-up. (2010)

Trial Status

Completed

Cancer Type

Liver Cancer

Publication Reference

  1. Tanis E, Julie C, Emile JF, Mauer M, Nordlinger B, Aust D, Roth A, Lutz MP, Gruenberger T, Wrba F, Sorbye H, Bechstein W, Schlag P, Fisseler A, Ruers T. Prognostic impact of immune response in resectable colorectal liver metastases treated by surgery alone or surgery with perioperative FOLFOX in the randomised EORTC study 40983. European Journal of Cancer 2015; 51(17): 2708–2717.
  2. Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T, for the EORTC Gastro-Intestinal Tract Cancer Group, Cancer Research UK Arbeitsgruppe Lebermetastasen und–tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO), Australasian Gastro-Intestinal Trials Group (AGITG), Fédération Francophone de Cancérologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncology 2013; 14(12): 1208–1215.
  3. Sorbye H, Mauer M, Gruenberger T, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Van Cutsem E, Scheithauer W, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK (CRUK); Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Fédération Francophone de Cancérologie Digestive (FFCD). Predictive factors for the benefit of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC Intergroup Trial 40983). Annals of Surgery 2012; 255(3): 534–539.
  4. Nordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Collette L, Praet M, Bethe U, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Fédération Francophone de Cancérologie Digestive (FFCD). Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet 2008; 371(9617): 1007–1016.

Conference Presentation Reference

  1. Nordlinger B, Sorbye H, Glimelius B, Poston G, Schlag P, Rougier P, Bechstein W, Primrose J, Walpole E, Mauer M, Gruenberger T, for the EORTC GI Group, CR UK, ALMCAO, AGITG, Nordic Group, and FFCD. EORTC liver metastases intergroup randomized phase III study 40983: long-term survival results. American Society of Clinical Oncology; 1–5 Jun 2012; Chicago.
  2. Sorbye H, Mauer M, Gruenberger T, Glimelius B, Poston G, Schlag P, Rougier P, Primrose J, Walpole E, Nordlinger B. Evaluation of carcinoembryonic antigen as a predictive baseline factor for the benefit of perioperative FOLFOX in resectable liver metastasis from colorectal cancer (EORTC study 40983). Gastrointestinal Cancers Symposium 2010.
  3. Sorbye H, Mauer M, Gruenberger T, Glimelius B, Poston G, Schlag P, Rougier P, Primrose J, Walpole E, Nordlinger B. Predictive factors for the effect of perioperative FOLFOX for resectable liver metastasis in colorectal cancer patients (EORTC phase III study 40983). American Society of Clinical Oncology Annual Meeting; 12-15 May 2010; San Francisco. Journal of Clinical Oncology 2010; 28(15S). Abstract 3544.
  4. Julié C, Lutz MP, Aust D, Kandutsch S, Collette L, Praet M, Gruenberger T, Van Cutsem E, Nordlinger B. Pathological analysis of hepatic injury after oxaliplatin-based neoadjuvant chemotherapy of colorectal cancer liver metastases: results of the EORTC Intergroup phase III study 40983. Gastrointestinal Cancers Symposium; 19–21 Jan 2007; Orlando. Abstract 241
  5. Nordlinger B, Sorbye H, Collette L, Praet M, Glimelius B, Poston G, Schlag P, Rougier P, Bechstein W, Primrose J, Walpole E, Finch-Jones M, Jaeck D, Mirza D, Parks R, Gruenberger T.. Survival after peri-operative chemotherapy with Folfox 4 and surgery for resectable colorectal cancer liver metastases. Final results of the EORTC Intergroup randomized phase III study 40983. World Congress on Gastrointestinal Cancer; 28 Jun–1 Jul 2007; Barcelona. Annals of Oncology 2007; 18(suppl.7): vii20.
  6. Nordlinger B, Sorbye H, Collette L, Glimelius B, Poston G, Schlag P, Rougier P, Bechstein W, Walpole E, Gruenberger T. Final results of the EORTC Intergroup randomized phase III study 40983 (EPOC) evaluating the benefit of peri-operative FOLFOX4 chemotherapy for patients with potentially resectable colorectal cancer liver metastases. 43rd Annual Meeting of the American Society of Clinical Oncology; 1-5 Jun 2007; Chicago. Journal of Clinical Oncology 2007; 25 (18S). Abstract LBA5.
  7. Gruenberger T, Sorbye H, Debois M, Bethe U, Primrose J, Rougier P, Jaeck D, Finch-Jones M, Van Cutsem E, Nordlinger B, EORTC GI group. Tumor response to preoperative chemotherapy with Folfox-4 for resectable colorectal cancer liver metastases. Interim results of EORTC Intergroup randomized phase III study 40983. 43rd Annual Meeting of the American Society of Clinical Oncology; 1–5 Jun 2006; Chicago. Journal of Clinical Oncology 2007; 24 (18S, Part I): 3500.
  8. Nordlinger B, Sorbye H, Debois M, Praet M, Glimelius B, Poston G, Schlag P, Walpole E, Bechstein W, Gruenberger T. Feasibility and risks of pre-operative chemotherapy with FOLFOX 4 and surgery for resectable colorectal cancer liver metastases. Interim results of the EORTC Intergroup randomized phase III study 40983. 42nd Annual Meeting of the American Society of Clinical Oncology; 2-6 Jun 2005; Atlanta. Journal of Clinical Oncology 2005; 23(16S): 3528.
  9. Walpole E, McCall J, Fawcett J, Zalcberg J, Schroeder J, Dhillon H, for the Australasian Gastro-Intestinal Trials Group. Randomised study of perioperative chemotherapy with infusional fluorouracil/leucovorin and oxaliplatin for liver metastases of colorectal cancer. Clinical Oncological Society of Australia Annual Scientific Meeting; 28-30 November 2001; Brisbane.

Aim

Cancers from the colon or rectum often spread to the liver (metastases). Sometimes these cancers can be removed from the liver with an operation, but the cancer often comes back later (recurs). This trial will determine if adding chemotherapy for three months before and after surgery can improve the cure and recurrence rates.

Summary

Surviving patients are now on yearly follow-up. (2010)

Principal Investigator

Dr Euan Walpole