Fast track multidiscipline treatment versus conventional treatment for colorectal cancer: The results of a prospective randomized controlled study (FTMDT trial).

743 Background: Fast Track Multi-Discipline Treatment (FTMDT) integrates fast-track perioperative treatment (laparoscopic or open surgery) plus XELOX adjuvant chemotherapy for colorectal cancer (CRC). This study aimed to verify the effects of FTMDT model and to clarify the value of laparoscopic surgery in fast-track perioperative treatment. Methods: The study (NCT01080547) was a prospective randomized controlled multi-centers study. Group I (FTMDT) received fast-track treatment plus XELOX chemotherapy (Group Ia received laparoscopic surgery and Group Ib received open surgery). Group II (conventional treatment, CT) received conventional treatment plus mFOLFOX6 chemotherapy (Group IIa received laparoscopic surgery and Group IIb received open surgery). The primary endpoint was total hospital stays during treatment. The secondary endpoints included surgical complications, chemotherapy related adverse events, quality of life and hospitalization costs. Results: Between April 2010 and June 2014, 374 patients were enrolled and 342 patients were finally analyzed. The total hospital stays were shorter in FTMDT than CT (median 13 days vs. 23.5 days, P= 0.0001) but similar between Group Ia and Group Ib (median 13 days vs. 14 days, P= 0.1951). The postoperative hospital stays were shorter in FTMDT than CT (median 6 days vs. 9 days, P= 0.0001) but similar between Group Ia and Group Ib (median 6 days vs. 6 days, P= 0.2160). Resume of flatus and defecation was earlier in FTMDT ( P< 0.05) and Group Ia was the earliest. The in-hospital complication rate was lower in FTMDT (6.40% vs. 14.71%, P= 0.014) but similar between Group Ia and Group Ib. The surgery cost of Group Ib was the lowest ( P< 0.05). The rate of chemotherapy related adverse events was similar between FTMDT and CT( P> 0.05). The EORTC QLQ-C30 physical functioning and fatigue in one week postoperative were better in FTMDT than CT( P< 0.05). Conclusions: FTMDT model enhanced the postoperative recovery of CRC patients. On the premise of fast-track perioperative treatment, laparoscopic surgery showed minor advantage over open surgery which had economic advantages. Clinical trial information: NCT01080547.

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Fast-track multidisciplinary treatment versus conventional treatment for colorectal cancer: a multicenter, open-label randomized controlled study

BMC Cancer ◽

10.1186/s12885-019-6188-x ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Jun Li ◽

Xiang-Xing Kong ◽

Jiao-Jiao Zhou ◽

Yong-Mao Song ◽

Xue-Feng Huang ◽

...

Keyword(s):

Colorectal Cancer ◽

Laparoscopic Surgery ◽

Hospital Stay ◽

Fast Track ◽

Multidisciplinary Treatment ◽

Controlled Study ◽

Perioperative Treatment ◽

Randomized Controlled ◽

Group 2 ◽

Group 1

Abstract Background Laparoscopic surgery, fast-track perioperative treatment and XELOX chemotherapy are effective strategies for shortening the duration of hospital stay for cancer patients. This trial aimed to clarify the safety and efficacy of the fast-track multidisciplinary treatment (FTMDT) model compared to conventional surgery combined with chemotherapy in Chinese colorectal cancer patients. Methods This trial was a prospective randomized controlled study with a 2 × 2 balanced factorial design and was conducted at six hospitals. Patients in group 1 (FTMDT) received fast-track perioperative treatment and XELOX adjuvant chemotherapy. Patients in group 2 (conventional treatment) received conventional perioperative treatment and mFOLFOX6 adjuvant chemotherapy. Subgroups 1a and 2a had laparoscopic surgery and subgroups 1b and 2b had open surgery. The primary endpoint was total length of hospital stay during treatment. Results A total of 374 patients were randomly assigned to the four subgroups, and 342 patients were finally analyzed, including 87 patients in subgroup 1a, 85 in subgroup 1b, 86 in subgroup 2a, and 84 in subgroup 2b. The total hospital stay of group 1 was shorter than that of group 2 [13 days, (IQR, 11–17 days) vs. 23.5 days (IQR, 15–42 days), P = 0.0001]. Compared to group 2, group 1 had lower surgical costs, fewer in-hospital complications and faster recovery (all P < 0.05). Subgroup 1a showed faster surgical recovery than that of subgroup 1b (all P < 0.05). There was no difference in 5-year overall survival between groups 1 and 2 [87.1% (95% CI, 80.7–91.5%) vs. 87.1% (95% CI, 80.8–91.4%), P = 0.7420]. Conclusions The FTMDT model, which integrates laparoscopic surgery, fast-track treatment, and XELOX chemotherapy, was the superior model for enhancing the recovery of Chinese patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547, registered on March 4, 2010.

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The Interim Analysis of Nutrition and Immune Recovery and Stress Response after Laparoscopy or Open Surgery with Fast Track or Conventional Treatment (FTMDT Trial) In Resectable Colorectal Cancer

Annals of Oncology ◽

10.1016/s0923-7534(20)33208-7 ◽

2012 ◽

Vol 23 ◽

pp. ix202-ix203

Author(s):

K.F. Ding ◽

D. Xu ◽

J. Li ◽

Y.M. Song ◽

J.W. Wang ◽

...

Keyword(s):

Colorectal Cancer ◽

Stress Response ◽

Interim Analysis ◽

Open Surgery ◽

Conventional Treatment ◽

Fast Track ◽

Immune Recovery

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Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

BMC Cancer ◽

10.1186/1471-2407-11-494 ◽

2011 ◽

Vol 11 (1) ◽

Cited By ~ 4

Author(s):

Jiao-Jiao Zhou ◽

Jun Li ◽

Xiao-Jiang Ying ◽

Yong-Mao Song ◽

Rong Chen ◽

...

Keyword(s):

Colorectal Cancer ◽

Conventional Treatment ◽

Fast Track ◽

Randomized Controlled Study ◽

Controlled Study ◽

Randomized Controlled

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Multicenter Randomized Controlled Trial of Conventional Versus Laparoscopic Surgery for Colorectal Cancer Within an Enhanced Recovery Programme: EnROL

Journal of Clinical Oncology ◽

10.1200/jco.2013.54.3694 ◽

2014 ◽

Vol 32 (17) ◽

pp. 1804-1811 ◽

Cited By ~ 105

Author(s):

Robin H. Kennedy ◽

E. Anne Francis ◽

Rose Wharton ◽

Jane M. Blazeby ◽

Philip Quirke ◽

...

Keyword(s):

Colorectal Cancer ◽

Laparoscopic Surgery ◽

Hospital Stay ◽

Open Surgery ◽

Enhanced Recovery ◽

Controlled Trial ◽

Physical Fatigue ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Secondary Outcomes

Purpose Laparoscopic resection and a multimodal approach known as an enhanced recovery program (ERP) have been major changes in colorectal perioperative care that have improved clinical outcomes for colorectal cancer resection. EnROL (Enhanced Recovery Open Versus Laparoscopic) is a multicenter randomized controlled trial examining whether the benefits of laparoscopy still exist when open surgery is optimized within an ERP. Patients and Methods Adults with colorectal cancer suitable for elective resection were randomly assigned at a ratio of 1:1 to laparoscopic or open surgery within an ERP, stratified by center, cancer site (colon v rectum), and age group (< 66 v 66-75 v > 75 years) using minimization. The primary outcome was physical fatigue at 1 month postsurgery. Secondary outcomes included hospital stay, complications, other patient-reported outcomes (PROs), and physical function. Patients and outcome assessors were blinded until 7 days postsurgery or discharge if earlier. Central independent and blinded pathologic assessment of surgical quality was undertaken. Results A total of 204 patients (laparoscopy, n = 103; open surgery, n = 101) were recruited from 12 UK centers from July 2008 to April 2012. One-month physical fatigue scores were similar in both groups (mean: laparoscopy, 12.28; 95% CI, 11.37 to 13.19 v open surgery, 12.05; 95% CI, 11.14 to 12.96; adjusted mean difference, −0.23; 95% CI, −1.52 to 1.07). Median total hospital stay was significantly shorter after laparoscopic surgery (median: laparoscopy, 5; interquartile range [IQR], 4 to 9 v open surgery, 7; IQR, 5 to 11 days; P = .033). There were no differences in other secondary outcomes or in specimen quality after central pathologic review. Conclusion In patients treated by experienced surgeons within an ERP, physical fatigue and other PROs were similar in both groups, but laparoscopic surgery significantly reduced length of hospital stay.

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