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SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

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ClinicalTrials.gov Identifier: NCT04039360
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital

Brief Summary:
This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Condition or disease Intervention/treatment
Complication of Treatment Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy

Detailed Description:
Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : November 30, 2015

Intervention Details:
  • Combination Product: self-expanding metallic stent placement followed by neoadjuvant chemotherapy
    Neoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.


Primary Outcome Measures :
  1. stoma rate [ Time Frame: 3 years after operation ]
    stoma rate after surgery



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
11 patients included seven (63.6%) men and four (36.4%) women. The median age of the patients was 67 years (range, 43-72 years)
Criteria

Inclusion Criteria:

  1. histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
  2. Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2

Exclusion Criteria:

  1. history of any other cancer
  2. multiple primary colorectal cancers
  3. distant metastases
  4. hereditary nonpolyposis colorectal cancer
  5. familial adenomatous polyposis
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Responsible Party: Zhen Jun Wang, Chairman of General Surgery, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04039360    
Other Study ID Numbers: SEMS-NCS-01
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen Jun Wang, Beijing Chao Yang Hospital:
Left-sided colonic tumor
Intestinal obstruction
Self-expanding metallic stent
Neoadjuvant chemotherapy
Stoma
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases