UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009432 |
|---|---|
| Receipt number | R000011084 |
| Scientific Title | A pilot study of the preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer aiming at sphincter preservation. |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2017/04/13 10:25:36 |
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Basic information
Public title
A pilot study of the preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer aiming at sphincter preservation.
Acronym
The preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer
Scientific Title
A pilot study of the preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer aiming at sphincter preservation.
Scientific Title:Acronym
The preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of UFT/LV+radiation of concurrent neo-adjuvant chemoradiotherapy for patleuts with T3-4 N0-2 rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Accomplishment rate of sphincter-preserving surgery with mesorectal excision.
Key secondary outcomes
1. Incidence of adverse events, surgical morbidity and mortality and postoperative QOL.
2. Macroscopic and pathological evaluation of primary lesion
3. Histological change of normal tissue in resected specimen
4. Disease free survival (DFS) and overall survival (OS)
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
Radiation2.0 Gy/day 25 times (5 weeks), total radiation 50Gy. Consisting of 5 weeks and 5 consecutive days of radiation followed by 2 days off. UFT 300mg/m2 and LV 75mg/day orally daily on days 1-5 rest 2 days every week for 5 weeks.
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
1. Age:20-75 years old
2. Performance status(ECOG):0-2
3. Histopathological confirmation of wel or mod adenocarcinoma
4. The main site the tumor is occupying is Ra or Rb
5. No metastasis of lymph node without region lymph node
6. Sufficient organs functions
7. No prior treatment for rectal cancer
8. Written informed consent
Key exclusion criteria
1. Patients with severe organ disfunction
2. Patients with uncontrollable ascites and pleural effusion
3. Patients with gastrointestinal bleeding
4. Patients with severe infection
5. Patients with severe complications
6. Synchronous or metachronous malignancy
7. Patients who have undergone abdominal radiotherapy
8. Patients with severe mental disorders
9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding.
10. Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Ishida |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
048-228-3619
05hishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Ishida |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive Tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
049-228-3619
Homepage URL
05hishi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
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
| 2012 | Year | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2017 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011084
