Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer

Last updated: February 4, 2021
Sponsor: Beijing Chao Yang Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stent

Colon Cancer

Chemotherapy

Treatment

N/A

Clinical Study ID

NCT02972541
2016-161-1
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Radiologically proven colonic obstruction of the left colon/upper rectum presumedsecondary 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 Wrightor Cockroft formula
  • Bilirubin less than 1.5×Upper Limit of Normal(ULN)
  • ALT and AST less than 2.5×ULN

Exclusion

Exclusion Criteria:

  • 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

Total Participants: 248
Study Start date:
September 30, 2016
Estimated Completion Date:
December 30, 2023

Connect with a study center

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Beijing Friendship Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • the Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • the First Affiliated Hospital of Guangxi Medical University

    Nanjing, Guangxi 530021
    China

    Active - Recruiting

  • Fourth Hospital of Hebei Medicial University

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

  • First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang 154003
    China

    Active - Recruiting

  • the 150th Central Hospital of Chinese PLA

    Luoyang, Henan 471031
    China

    Active - Recruiting

  • the First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • the Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Hubei General Hospital

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Active - Recruiting

  • Hunan Provincial People'S Hospital

    Changsha, Hunan 410005
    China

    Active - Recruiting

  • the Third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin 130033
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • the First Affiliated Hospital of Dalian Medical University

    Dalian, Shandong 116011
    China

    Active - Recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jin'an, Shandong 250014
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250022
    China

    Active - Recruiting

  • Shandong General Hospital

    Jinan Shi, Shandong 250021
    China

    Active - Recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jinan Shi, Shandong 250014
    China

    Active - Recruiting

  • the Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Changhai Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Shanxi Tumor Hospital

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • the First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • the First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Jinhua Hospital of Zhejiang University

    Jinhua, Zhejiang 321000
    China

    Active - Recruiting

  • the Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325027
    China

    Active - Recruiting

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