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Poster display session

1429 - Updated survival results of FACT trial: Multicenter phase II trial of neoadjuvant chemotherapy with mFOLFOX6 for stage II/III rectal cancer with a T3/T4 tumor.


09 Sep 2017


Poster display session


Hirotoshi Hasegawa


H. Hasegawa1, K. Okabayashi1, M. Tsuruta1, J. Koike2, K. Funahashi2, H. Yokomizo3, K. Yoshimatsu3, H. Kan4, T. Yamada4, H. Ishida5, K. Ishibashi5, Y. Saida6, T. Enomoto6, K. Katsumata7, K. Koda8, T. Ochiai9, K. Sakamoto10, S. Ogawa11, M. Itabashi11, S. Kameoka11

Author affiliations

  • 1 Department Of Surgery, Keio University School of Medicine, 1608582 - Tokyo/JP
  • 2 Department Of Gastroenterological Surgery, Toho university Medical Center Oomori Hospital, 1438541 - Tokyo/JP
  • 3 Department Of Surgery, Tokyo Women's Medical University Medical Center East, 116-8567 - Tokyo/JP
  • 4 Departments Of Gastrointestinal And Hepato-biliary-pancreatic Surgery, Nippon Medical School Main Hospital, 113-8603 - Tokyo/JP
  • 5 Department Of Digestive Tract And General Surgery, Saitama Medical Center, Saitama Medical University, 350-8550 - Saitama/JP
  • 6 Department Of Surgery, Toho University Ohashi Medical Center, 153-8515 - Tokyo/JP
  • 7 Department Of Digestive Surgery And Pediatric Surgery, Tokyo Medical University Hospital, 160-0023 - Tokyo/JP
  • 8 Department Of Surgery, Teikyo University Chiba Medical Center, 299-0111 - Ichihara/JP
  • 9 Department Of Surgery, Tobu Chiiki Hospital, 125-8512 - Tokyo/JP
  • 10 Department Of Coloproctological Surgery, Faculty Of Medicine,, Juntendo University School of Medicine, 113-0033 - Tokyo/JP
  • 11 Department Of Surgery, Institute Of Gastroenterology, Tokyo Women’s Medical University, 162-8666 - Tokyo/JP


Abstract 1429


The multicenter phase II FACT trial demonstrated that modified FOLFOX6 (mFOLFOX6) was efficacious treatment for stage II/III rectal cancer patients with a T3/T4 tumor (Koike J, et al. Cancer Chemother Pharmacol 2017). We now reported the disease free survival (DFS) and overall suravival (OS) after a median follow-up of more than 3 years.


Patients received four 2-week cycles of mFOLFOX6 therapy (oxaliplatin at 85 mg/m2 + l-leucovorin at 200 mg/m2 + fluorouracil as a 400 mg/m2 bolus followed by infusion of 2,400 mg/m2 over 46 hours, all on Day 1). They were evaluated by computed tomography after completion of the fourth cycle. If there was no disease progression, two additional cycles were administered and then surgery was performed. Adjuvant chemotherapy was generally administered for 6 months using various regimens at the discretion of the physician.


At a median follow-up of 42.8 months, median DFS from registration of clinical trials was 42.2 months, and median DFS from surgery was 38.9 months. Median survival time (MST) from registration of clinical trials was 42.8 months, and OS from surgery was 38.9 months. The safety profile was almost similar to previous analysis results.


Neoadjuvant chemotherapy using mFOLFOX6 for stage II/III rectal cancer patients with a T3/T4 tumor was well tolerated, as previously reported. In this trial, neoadjuvant mFOLFOX6 showed improved median DFS and MST.

Clinical trial identification

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