UMIN-CTR Clinical Trial

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

Colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

NPO JORTC

Institute

Department

Personal name

Organization

The Colonic Stent Safe Procedure Research Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

02

Month

16

Day

Last modified on

2018

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029703