UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011993 |
|---|---|
| Receipt number | R000014016 |
| Scientific Title | Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer |
| Date of disclosure of the study information | 2013/10/09 |
| Last modified on | 2025/05/03 11:25:47 |
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Basic information
Public title
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Acronym
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Scientific Title
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Scientific Title:Acronym
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Locally advanced rectal cancer
Locally advanced anal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with S-1 and irinotecan in patients with locally advanced rectal cancer.
Basic objectives2
Others
Basic objectives -Others
To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for tumor regression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathological Complete Response rate
Predictive value for tumor regression
Key secondary outcomes
Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1(80mg/m2/day1-5,8-12,22-26,29-33)
irinotecan(80mg/m2/day1,8,22,29)
Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III.
(2) Histologically confirmed adenocarcinoma
(3) Without prior anti-tumor therapy
(4) Age:20-80years old
(5) Performance status 0-2
(6) Adequate organ function
WBC>= 4,000 <= 15,000/mm3
neutro>= 2,000/mm3
Plt>= 100,000/mm3
Hb>= 8.0g/dl
Cr<= 1.5mg/dl
T-Bil<= 1.5mg/dl
AST, ALT<= double of the upper limit
(7) Written IC with date
Key exclusion criteria
Patients judged inappropriate for this study by the physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hase |
Organization
National Defense Medical College
Division name
Surgery
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
04-2995-1511
shinto@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shinto |
Organization
National Defense Medical College
Division name
Surgery
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
04-2995-1511
Homepage URL
shinto@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2 Namiki Tokorozawa Saitama
Tel
04-2995-1511
shinto@ndmc.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
| 2013 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
https://academic.oup.com/bjsopen/article/4/2/301/6061323
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/bjsopen/article/4/2/301/6061323
Number of participants that the trial has enrolled
49
Results
Assessment of CD133, COX-2 and CD8 could be useful in predicting a good response to preoperative CRT in patients with lower rectal cancer undergoing neoadjuvant therapy. Further studies are needed to validate the results in larger cohorts and investigate a survival benefit.
A prospective trial involving patients with only two or three positive findings for treatment using preoperative CRT (study ID: UMIN000026306) is currently ongoing, to obtain more robust findings.
Results date posted
| 2025 | Year | 05 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All consecutive patients with stage II-III rectal cancer undergoing long-term preoperative CRT followed by surgery, were included. Preoperative CRT was indicated for patients with cT3-4 low rectal cancer where the distal margin was located below the peritoneal reflection. Forty-nine patients were enrolled prospectively. Between 2011 and 2013, 13 patients received 80 mg/m2 irinotecan (UMIN000011993). However, seven of these 13 patients developed grade III or higher adverse events, such as diarrhoea (3 patients), neutropenia (4) and anorexia (1). Thus, from patient 14 onwards, only S-1 was administered between 2014 and 2017 (UMIN000013486).
Participant flow
Pretreatment biopsies were stained immunohistochemically using antibodies to determine CD133 and COX-2 expression, and increased CD8+ density. Patients were treated with long-term preoperative CRT (45Gy (25 daily doses of 1.8Gy), and S-1 with/without irinotecan), followed by total mesorectal excision.
Adverse events
Forty-nine patients were enrolled prospectively. Between 2011 and 2013, 13 patients received 80 mg/m2 irinotecan (UMIN000011993). However, seven of these 13 patients developed grade III or higher adverse events, such as diarrhoea (3 patients), neutropenia (4) and anorexia (1). Thus, from patient 14 onwards, only S-1 was administered between 2014 and 2017 (UMIN000013486). After the change of regimen, only 3 patients developed grade III adverse events, such as diarrhoea (1), neutropenia (2) .
Outcome measures
Outcome measures were tumour regression grade (TRG), tumour downstaging and survival. TRG was assessed semiquantitatively using haematoxylin and eosin-stained slides. Tumour downstaging was defined as pathological findings of ypT0-2, because all cancers had been estimated to be cT3-4 according to inclusion criteria.Local recurrence-free survival was defined as the time from surgery to local recurrence in patients with rectal cancer, whereas relapse-free survival was defined as the time to the first relapse or death from any cause.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014016
