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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026158
Receipt No. R000029703
Scientific Title Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer
Date of disclosure of the study information 2017/02/16
Last modified on 2018/02/20

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Basic information
Public title Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer
Acronym COBRA Trial
Scientific Title Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer
Scientific Title:Acronym COBRA Trial
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 COBRA trial is a phase III randomized controlled trial to verify whether the decompression with colonic stenting for obstructive colorectal cancer (CRC) will show the non-inferiority in long-term prognosis of CRC against surgery with fasting as standard treatment.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival at 3 years
Key secondary outcomes Overall survival
Relapse-free survival
Quality of life
Incidence of obstructive symptoms (Bloating, abdominal pain/crump, deterioration of bowel habit, nausea or vomiting) before surgery
Incidence of emergency surgery
Withdrawal rate of continuous infusion IV
Technical success rate of colonic stenting
Clinical success rate of colonic stenting
Clinical success rate of colonic stenting at BTS
Complication rate and onset period with colonic stenting
Perioperative complication rate
Primary anastomosis rate
Permanent stoma formation rate
Induction rate of adjuvant chemotherapy

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Colonic stenting within 7 days and primary tumor resection within 3-30 days after allocation
Interventions/Control_2 After management by fasting or liquid intake, primary tumor resection within 3-30 days after allocation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Radiologically (Abdominal and pelvic CT) or endoscopically proven colonic stricture presumed secondary to a carcinoma
2) Primary tumor should be located in one of ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid colon, and a lesion which is located in ileocecal valve, rectum above the peritoneal reflection, or rectum less than 10cm from anal verge is excluded.
3) Colonic stricture which is impossible to be passed through by colonoscope including a small-caliber one, and the degree of colonic stricture is estimated as colorectal obstruction scoring system (CROSS) 1 or 2.
4) Colonic stricture presumed secondary to a carcinoma by preoperative imaging modalities such as abdominal and chest X-ray, abdominal and pelvic CT, chest CT, abdominal MRI, abdominal ultrasound or FDG-PET
5) Patient with at least one of the following obstructive findings;
1. Intolerable for oral intake or necessary for fasting at the judgement of the attending physician
2. No fart
3. Bloating or abdominal pain
4. Abnormality of defecation such as constipation or frequent diarrhea
5. Nausea or vomiting
6) Patient without gastrointestinal decompressive procedure such as long intestinal tube, transanal drainage tube or colonic stenting
7) Patient diagnosed as stage II or III colorectal cancer in preoperative imaging modalities such as abdominal and chest X-ray, abdominal and pelvic CT, chest CT, abdominal MRI, abdominal ultrasound or FDG-PET
8) Patient with ECOG performance status of 0, 1, or 2
9) Patient aged 20 to 90
10) Patient without chemotherapy or radiotherapy for any cancer when allocated
11) Organ function is preserved
12) Written informed consent to participation in this trial
Key exclusion criteria 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (Carcinoma in situ or other early carcinoma is excluded)
2) Women who are pregnant, possible to be pregnant or provide breastfeeding
3) Patient with severe comorbidity of heart, lung, liver and kidney
4) Patient with cerebrovascular disorder including unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, transient cerebral ischemia or thromboembolism within 6 months before registration
5) Patient with aortic dissection or aortic aneurysm of more than 5cm in abdomen or more than 6cm in thorax
6) Patient with diathesis of bleeding or coagulopathy because of decrease in platelets/clotting factor (excluding coagulopathy with preventive antithrombotic agents)
7) History of hemoptysis with bright red blood more than teaspoon 1/2 cup [2.5ml]) within 4 weeks
8) Patient with infectious disease to need systemic treatment
9) History of fistula, gastrointestinal perforation, or abscess in the abdominal cavity
10) Patient with difficulty in participation to clinical trial because of psychosis or mental disorder
11) Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size 420

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Saida
Organization Toho University Ohashi Medical Center
Division name Department of Surgery
Zip code
Address 2-17-6 Ohashi, Meguro-ku, Tokyo, 153-8515, Japan
TEL 03-3468-1251
Email yoshisaida@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Shuntaro Yoshida
Organization University of Tokyo
Division name Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL 03-3815-5411
Homepage URL
Email shungtang@hotmail.com

Sponsor
Institute NPO JORTC
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization The Colonic Stent Safe Procedure Research Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 16 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029703


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