UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039169 |
|---|---|
| Receipt number | 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 20:54:41 |
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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
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/
t.koedam@vumc.nl
Sponsor or person
Institute
National cancer center east hospital
colorectal surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044666
