Complication of TreatmentNCT04039360
SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer
An observational study of Complication of Treatment, run by Beijing Chao Yang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complication of Treatment
- What is being tested?
- self-expanding metallic stent placement followed by neoadjuvant chemotherapy
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 30 Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
- Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2
Who cannot join
- history of any other cancer
- multiple primary colorectal cancers
- distant metastases
- hereditary nonpolyposis colorectal cancer
- familial adenomatous polyposis
About this study
Official title: Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer
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.
Read the 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.
- Conditions
- Complication of Treatment
- Being tested
- self-expanding metallic stent placement followed by neoadjuvant chemotherapy
- Keywords
- Left-sided colonic tumor, Intestinal obstruction, Self-expanding metallic stent, Neoadjuvant chemotherapy, Stoma
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-expanding metallic stent placement followed by neoadjuvant chemotherapyCombination product
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
stoma rate
stoma rate after surgery
Measured: 3 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 May 2014
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039360
- Sponsor's protocol ID
- SEMS-NCS-01
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer
- ClinicalTrials.gov ID
- NCT04039360
- Acronym / sponsor ID
- SEMS-NCS-01
- Conditions
- Complication of Treatment
- Keywords
- Left-sided colonic tumor, Intestinal obstruction, Self-expanding metallic stent, Neoadjuvant chemotherapy, Stoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin)
- Eastern Cooperative Oncology Group (ECOG) performance status of from 0 to 2
Key exclusion criteria (5 listed)
- history of any other cancer
- multiple primary colorectal cancers
- distant metastases
- hereditary nonpolyposis colorectal cancer
- familial adenomatous polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-expanding metallic stent placement followed by neoadjuvant chemotherapyNeoadjuvant 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. | Combination product | – |
Primary outcome
stoma rate
Time frame: 3 years after operation
stoma rate after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Treatment, run by Beijing Chao Yang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stoma rate (time frame: 3 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.