UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034364 |
|---|---|
| Receipt number | R000039089 |
| Scientific Title | Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial |
| Date of disclosure of the study information | 2018/10/03 |
| Last modified on | 2025/02/24 20:42:46 |
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Basic information
Public title
Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial
Acronym
PRODUCT trial
Scientific Title
Prospective Study Investigating Laparoscopic Surgery for Locally Advanced Rectal Cancer with Evaluation of CRM and TME quality: PRODUCT trial
Scientific Title:Acronym
PRODUCT trial
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate oncological feasibility of laparoscopic or robot-assisted surgery for rectal cancer by assessing CRM and TME using the appropriate method to measure CRM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative rate for CRM (>1mm)
Key secondary outcomes
Quality of TME (complete or nearly complete or incomplete)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Rectal cancer (less than or equal to 12 cm from the anal verge)
cStage II, III
Scheduled for laparoscopic surgery or robot-assisted surgery
Age greater than or equal to 20 years
Key exclusion criteria
The depth of invasion is cT4b
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL
011-611-2111
jpcrm@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hamabe |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo-shi, Hokkaidou
TEL
011-611-2111
Homepage URL
ahamabe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University, Department of Surgery, Surgical Oncology and Science
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University, Department of Surgery, Surgical Oncology and Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwate Medical University
Oita University
Cancer Institute Hospital
Kitasato University
Kyoto University
Kindai University
National Cancer Center Hospital East
Kouseiren Takaoka Hospital
Saitama Medical University International Medical Center
Juntendo University
Toranomon Hospital
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Nagoya University
Hyogo College Of Medicine
Fukuoka University
Fujisawa City Hospital
Fujita Health University
Yokohama City University Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo-shi, Hokkaidou
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
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
| 2018 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36338586/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36338586/
Number of participants that the trial has enrolled
308
Results
The median CRM was 4.0 mm (IQR, 2.1-8.0 mm), and CRM was positive in 26 cases (8.6%). Univariate and multivariate analyses demonstrated that a predicted CRM from the mesorectal fascia being 1 mm or less on MRI was the significant factor for positive CRM (P = .0012 and P = .0045, respectively).
Results date posted
| 2025 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 303 patients operated on between August 2018 and January 2020 were included in the primary analysis. The number of patients with clinical stage II and III was 139 and 164, respectively. Upfront surgery was performed for 213 patients and neoadjuvant therapy for 90 patients.
Participant flow
As stated above.
Adverse events
Regarding postoperative complications (Clavien-Dindo is grade III or greater), anastomotic leakage was found in 22 cases (rate of leakage, 7.3%), surgical site infection other than leakage in 10 cases, bowel obstruction in eight cases, paralytic ileus in 10 cases, and other complications in 30 cases.
Outcome measures
The primary outcome was a pathological CRM measured using the semi-opened circular specimen processing method. CRM was defined as negative if the distance between the closest tumor invasion and dissected plane was more than 1 mm. The secondary outcomes included the quality of TME, surgical and pathological findings, disease-free survival, overall survival, and local recurrence rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Assessment for CRM negative rate and quality of TME
Management information
Registered date
| 2018 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039089
