UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023621 |
|---|---|
| Receipt number | R000027202 |
| Scientific Title | A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2019/08/31 10:58:52 |
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Basic information
Public title
A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Acronym
A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Scientific Title
A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Scientific Title:Acronym
A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility and efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Response rate, overall and disease-free survival, quality of life, adverse events, postoperative complications, pathological complete response rate, and diagnostic accuracy of MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
preoperative chemoradiotherapy+surgery
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
# Pathologically proven adenocarcinoma.
# Primary tumor located at Upper rectum, Lower rectum, and Anal canal. The lower border of the tumor located between the peritoneal reflection and the anal verge.
# cT3 and cT4a tumor with a distance of less than 2 mm between tumor and mesorectal fascia on MRI
# No Lateral lymph nodes (5mm and more in short axis diameter) on MRI data
# No distant metastasis on contrast-enhanced CT or MRI (cM0)
# Aged 20 to 75 years old
# Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
# Adequate organ function as evidenced by the following laboratory studies and symptoms within 14 days prior to enrollment
1) White blood count >= 2,000 /mm3
2) Neutrophil count >= 1,000 /mm3
3) Platelet count >= 75,000 /mm3
4) Fever <= 38.0C
5) Diarrhea=< Grade 2 (CTCAE ver.4.0)
6) Stomatitis=< Grade 2
7) Total bilirubin=< Grade 2
8) AST /ALT =< Grade 2
9) Cr =< Grade 2
# Written informed consent
Key exclusion criteria
# Distant metastases
# Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year.
# Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year.
# Cancerous fluid on diagnostic imaging.
# Prior chemotherapy or pelvic irradiation for malignancy.
# Other cancer diagnosis within the past 5 years (including colorectal cancer).
# Interstitial pneumonia or fibroid lung.
# Uncontrolled diabetes mellitus.
# Uncontrolled hypertension
# Ileus (cases with diverting stoma are eligible).
# Uncontrolled diarrhea.
# Pregnant, nursing or no intention to contraception.
# Those considered inappropriate for participation in this trial.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyotaka Okuno, MD |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
k-okuno@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Kawamura, MD |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
Homepage URL
http://www.kindai-geka.jp/general/endoscopic/transition.html
kawamuraj@med.kindai.ac.jp
Sponsor or person
Institute
Department of Surgery
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2016 | Year | 08 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 08 | 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
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027202
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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