UMIN-CTR Clinical Trial

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