Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
- Conditions
- StentColorectal CancerObstructionNeoadjuvant Chemotherapy
- Interventions
- Device: Stenting with immediate SurgeryDevice: Stenting with neoadjuvant chemotherapy
- Registration Number
- NCT02972541
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 248
- Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
- Able to give written, informed consent
- Primary tumor was resectable
- ECOG score 0 or 1
- Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
- White blood cells greater than 3.0×10⁹ /L
- Platelets greater than 100×10⁹ / L;
- Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula
- Bilirubin less than 1.5×Upper Limit of Normal(ULN)
- ALT and AST less than 2.5×ULN
- Distal rectal cancers(equal or less than 10cm from the anal verge)
- Patients with signs of peritonitis and/or bowel perforation
- Patients who did not give informed consent
- Patients who were considered unfit for operative treatment or refuse surgery.
- Patients with suspected or proven metastatic adenocarcinoma;
- Patients with unresectable colorectal cancer, or planning for palliative treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stenting with Immediate Surgery Stenting with immediate Surgery After clinical success of colonic stenting, patients will undergo surgery 7-14 days after inclusion. Type and extent of the elective surgery will be selected by the surgeon. Stenting with neoadjuvant chemotherapy Stenting with neoadjuvant chemotherapy After clinical success of colonic stenting, patients will receive neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 3-5 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon.
- Primary Outcome Measures
Name Time Method Overall survival From date of randomization until the date of death from any cause, assessed up to 5 years Disease free survival From date of randomization until the date of tumor recurrence or death from any cause, assessed up to 5 years Rate of stoma formation From date of randomization until the follow-up ended, assessed up to 5 years
- Secondary Outcome Measures
Name Time Method Rates of primary colorectal anastomosis From date of randomization until the first follow-up ended, assessed up to 30 days The primary colorectal anastomosis was defined as: the patients received one-stage surgery and colorectal anastomosis.
Chemotherapy complete rate From date of randomization until the chemotherapy ended, assessed up to 1 years Chemotherapy related complication From date of randomization until the chemotherapy ended, assessed up to 1 years Surgical complication From date of randomization until the first follow-up ended, assessed up to 30 days Including but not limited to: anastomotic leakage, wound infection, intra-abdominal sepsis,perioperative mortality, etc.
R0 resection rate From date of randomization until the first follow-up ended, assessed up to 30 days R0 resection is defined as negative resection margins and no residual tumor.
Re-operation rate From date of randomization until the follow-up ended, assessed up to 5 years
Trial Locations
- Locations (32)
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
the Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
the First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanjing, Guangxi, China
the Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Fourth Hospital of Hebei Medicial University
🇨🇳Shijiazhuang, Hebei, China
First Affiliated Hospital of Jiamusi University
🇨🇳Jiamusi, Heilongjiang, China
the 150th Central Hospital of Chinese PLA
🇨🇳Luoyang, Henan, China
the First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
the Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hubei General Hospital
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong General Hospital
🇨🇳Jinan Shi, Shandong, China
Hunan Provincial People'S Hospital
🇨🇳Changsha, Hunan, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
the First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Shandong, China
Shandong Provincial Qianfoshan Hospital
🇨🇳Jinan Shi, Shandong, China
the Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Shanxi Tumor Hospital
🇨🇳Taiyuan, Shanxi, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
the First Affiliated Hospital of Xi'An Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
the First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Jinhua Hospital of Zhejiang University
🇨🇳Jinhua, Zhejiang, China
the Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China