UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063288 |
|---|---|
| Receipt number | R000072413 |
| Scientific Title | Prospective Cohort Study to Clarify the clinical benefit of lateral Pelvic Lymph node Dissection in Low Rectal Cancer |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 10:31:09 |
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Basic information
Public title
Prospective Cohort Study to Clarify the clinical benefit of lateral Pelvic Lymph node Dissection in Low Rectal Cancer
Acronym
PLANET study
Scientific Title
Prospective Cohort Study to Clarify the clinical benefit of lateral Pelvic Lymph node Dissection in Low Rectal Cancer
Scientific Title:Acronym
PLANET study
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefit of lateral pelvic lymph node dissection (LLND) and reconsider the optimal patient population and dissection extent in low rectal cancer patients undergoing rectal resection with LLND.
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
1-year local recurrence rate, overall survival, recurrence-free survival, station-specific lateral nodal metastasis rate, sites of local recurrence, operative time, blood loss, incidence of adverse events, incidence of sexual dysfunction, incidence of urinary dysfunction
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed adenocarcinoma (including mucinous carcinoma and signet-ring cell carcinoma) according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (9th edition) by preoperative endoscopic biopsy of the primary colorectal lesion
2.Primary tumor located in the low rectum or anal canal, or the lower border of the tumor located in the low rectum, meeting at least one of the following:
Depth of tumor invasion is clinical T2 or deeper
Lateral pelvic lymph node metastasis is suspected on preoperative imaging (evaluated according to institutional criteria)
Mesorectal lymph node metastasis is suspected on preoperative imaging (evaluated according to institutional criteria)
3.No prior chemotherapy or radiotherapy for rectal cancer
4.Scheduled for primary rectal resection combined with bilateral lateral pelvic lymph node dissection (open, laparoscopic, or robotic approaches are all permitted)
5.No prior history of surgery, chemotherapy, or radiotherapy for pelvic tumors (e.g., rectal cancer, gynecological malignancies, urological malignancies)
6.No multiple cancers on preoperative imaging, and absence of distant organ metastasis, distant lymph node metastasis, and peritoneal dissemination (not cStage IV)
7.Age 20 to 79 years at enrollment
8.Written informed consent obtained from the patient
Key exclusion criteria
1.Patients who do not provide written informed consent
2.Patients judged unsuitable for study participation by the attending physician
Target sample size
840
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Kanemitsu |
Organization
National Cancer Center Hospital
Division name
Department of Colorectal Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
ykanemit@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Takamizawa |
Organization
National Cancer Center Hospital
Division name
Department of Colorectal Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
ytakamiz@ncc.go.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum (JSCCR)
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Cancer of the Colon and Rectum (JSCCR)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.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
| 2026 | Year | 10 | Month | 15 | 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
840
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a nationwide, multicenter prospective observational cohort study of patients with low rectal or anal canal cancer undergoing standard bilateral lateral pelvic lymph node dissection (open, laparoscopic, or robot-assisted) according to the Japanese Classification and JSCCR guidelines in routine clinical practice. Clinical data, including baseline demographics, preoperative findings (endoscopy, staging imaging), surgical parameters (dissection extent, operative time, blood loss, nerve preservation, intra- and postoperative complications), and histopathological findings (T category, station-specific nodal metastasis, circumferential resection margin), are collected prospectively. Patients are followed prospectively for 3 years after the completion of enrollment, with detailed follow-up at 1 and 3 years postoperatively to assess oncological outcomes (overall survival, recurrence-free survival, local recurrence rate and sites), adjuvant therapy, and functional morbidity (urinary and sexual dysfunctions). All data are centrally managed in a linked-anonymized manner through the data center of the NPO Epidemiological and Clinical Research Information Network (ECRIN).
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072413
