Colorectal cancer is the fourth most common cancer in China. Up to 30% of patients with colorectal cancer present with an emergency obstruction of the large bowel at the time of diagnosis, and 70% of all malignant obstruction occurs in the left-sided colon. Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore，the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. We hypothesis that immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
After clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
After clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGChinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Disease free survival
Time frame: From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
Rate of stoma formation
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Surgical complication
Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis,perioperative mortality, etc.
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Rates of primary colorectal anastomosis
The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis.
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
R0 resection rate
R0 resection is defined as negative resection margins and no residual tumor.
Time frame: From date of randomization until the first follow-up ended, assessed up to 30 days
Re-operation rate
Time frame: From date of randomization until the follow-up ended, assessed up to 5 years
Chemotherapy complete rate
Time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
Chemotherapy related complication
Time frame: From date of randomization until the chemotherapy ended, assessed up to 1 years
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGDepartment of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGthe Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGthe First Affiliated Hospital of Guangxi Medical University
Nanjing, Guangxi, China
RECRUITINGFourth Hospital of Hebei Medicial University
Shijiazhuang, Hebei, China
RECRUITINGFirst Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
RECRUITING...and 22 more locations