UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Colonic stent for "Bridge to Surgery" prospective randomized controlled trial comparing treatment with non-stenting surgery in stage II/III obstructive colon cancer
Title of the study (Brief title)	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

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

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	Yoshihisa Saida
Organization	Toho University Ohashi Medical Center
Division name	Department of Surgery
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	Shuntaro Yoshida
Organization	University of Tokyo
Division name	Gastroenterology
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

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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