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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039169
Receipt No. R000044666
Scientific Title a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer.
Date of disclosure of the study information 2020/01/31
Last modified on 2020/01/15

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Basic information
Public title a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer.
Acronym COLOR III trial
Scientific Title a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer.
Scientific Title:Acronym COLOR III trial
Region
Japan Asia(except Japan) North America
Europe

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

Objectives
Narrative objectives1 The objective of this trial to evaluate the safety and efficacy TaTME for patients with mid and low rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year local recurrence rate
Key secondary outcomes quality of specimen, involved CRM, morbidity & mortalityresidual mesorectum, DFS, OS, sphincter saving procedures, functional outcome, HrQoL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 TaTME
Interventions/Control_2 Laparoscopic TME
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Solitary adenocarcinoma rectal cancer within 10 cm from anal verge defined by MRI
2) Stage 1-3 according to the AJCC classification including downstaged tumours based on adequate imaging of the thorax and abdomen
3) Intention for LAR with colorectal anastomosis or with coloanal anastomosis
4) Suitable for elective laparoscopic surgical resection
5) Informed consent according to local requirements
Key exclusion criteria 1) T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRIscan (staged after (chemo)radiotherapy if applicable)
2) Intention for APR
3) Malignancy other than adenocarcinoma at histological examination
4) Patients under 18 years of age
5) Pregnancy
6) Previous prostate or rectal surgery (excluding local excision)
8) Signs of acute intestinal obstruction
9) Multiple colorectal tumors

11) Planned synchronous abdominal organ resections
12) Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
10) Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis
13) Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as sever cardiovascular or respiratory disease
Target sample size 1104

Research contact person
Name of lead principal investigator
1st name H.J. (JAAP)
Middle name
Last name Bonjer
Organization VU Uniersity Medical Centre
Division name Department of Surgery
Zip code 1081 HV
Address VU University Medical Centre Department of Surgery De Boelelaan 1117 HV Amsterdam, The Netherlands
TEL 31204444781
Email t.koedam@vumc.nl

Public contact
Name of contact person
1st name Jurriaan
Middle name
Last name Tuynman
Organization VU University Medical Centre
Division name Department of Surgery
Zip code 1081 HV
Address VU University Medical Centre Department of Surgery De Boelelaan 1117 HV Amsterdam, The Netherlands
TEL 31204444781
Homepage URL https://www.color3trial.com/
Email t.koedam@vumc.nl

Sponsor
Institute National cancer center east hospital
colorectal surgery
Institute
Department

Funding Source
Organization VU University Medical Centre
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National cancer center east hospital
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan
Tel 04-7133-1111
Email maito@east.ncc.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02736942
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions KH der Barmherzigen Bruder,Graz,Austria
Health Sciences North in Sudbury,Toront,Canada
Friendship Hospital,Beijing,China
Sun Yat-Sen Cancer center,Taipei,China
Caritas st Josef,Regensburg,Germany
Charite,Berlin,Germany
Johanniter,Bonn,Germany
Ammerland Klinik,Ammerland,Germany
Vumc,Amsterdam,Netherlands
Gelderse vallei,Ede,Netherlands
AMC,Amsterdam,Netherlands
Spaarne gasthuis,Haarlem,Netherlands
Ijsselland,Capelle a/d IJssel,Netherlands
Deventer ziekenhuis,Deventer,Netherlands
Krakow,Krakow,Poland
Braga,Braga,Portugal
Hospital Clinic,Barcelona,Spain
Umass,Boston,USA
Hongkong University,Hongkong,China
The affiliated Nanchong Central Hospital,Nanchong,China
Agnelli Hospital,Pinerolo,Italy
National Cancer Center,Goyang,Korea
First Affiliated Hospital to Chongqing medical university,FAH Chongqing,China
Daping Hospital, Army Medical University,Chongqing,China
First hosptial of Jilin univeristy,Changchun,China
Shanghai Jiaotong University Renji Hospital,Shanghai,China
National cancer center east hospital,Chiba,Japan

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 22 Day
Date of IRB
2019 Year 12 Month 20 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 15 Day
Last modified on
2020 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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