UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013383 |
|---|---|
| Receipt number | R000015617 |
| Scientific Title | A phase 2 clinical trial of preoperative chemoradiation therapy for locally advanced low rectal cancer with limited radiation field to the lesser pelvis |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2015/08/19 14:52:55 |
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Basic information
Public title
A phase 2 clinical trial of preoperative chemoradiation therapy for locally advanced low rectal cancer with limited radiation field to the lesser pelvis
Acronym
OCD1401
Scientific Title
A phase 2 clinical trial of preoperative chemoradiation therapy for locally advanced low rectal cancer with limited radiation field to the lesser pelvis
Scientific Title:Acronym
OCD1401
Region
| Japan |
Condition
Condition
Locally advanced low rectal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative chemoradiation therapy in patients with locally advanced low rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological local effect
Key secondary outcomes
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
a. Xeloda 1700 mg/m2/Day
b. UFT 300mg/m2/Day USEL 75mg/body/Day
c. Radiation Therapy 50GY 2x25 times
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.Age over 20 and under 80
2.Performance Status 0-2
3.Adenocarcinoma in pathological diagnosis
4.Rectal cancer reached the area of Rb.
5.Tumor progression is T3 or N positive. Alternatively, it should be T2 which is difficult to treat with anus-conserving surgery.
6.A minor axis 8mm is positive with a decision of lymph node metastasis
7. Vital organ functions (listed below) are preserved.
1) WBC>=4,000/ul and WBC<12,000u/l
2) Platelet>100,000/ul
3) GOT and GPT: under 2.5x upper limit of normal.
4) T-Bil<=1.5mg/dL
5) BUN<=25mg/dL
6) Cr<=1.5mg/dL
7) Normal ECG (clinically qualified with an irregular pulse and ischemic change)
8. Patients who have not previously treated with rectal cancer
9. Written informed consent
Key exclusion criteria
1. Distant metastasis or inguinal lymph node metastasis is positive
2. Serious organ derangement
3.Patient with ascetic fluid and pleural effusion which are needed a drainage
4. Patient with constant bleeding from the alimentary canal
5. Patient with active infection
6. Patient with serious disease condition (paresis of intestine, interstitial pneumonia, intestinal blockage, diabetes mellitus, etc)
7. Patient with active double cancer. (Exclude disease free interval over 5 years)
8. Patient has ventral pre-existing in radiation therapy
9. Patient with impaired mental status.
10. Pregnancy
11. Other ineligible status judged by attending doctor.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Asao |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Oncology Clinical Development
Zip code
Address
3-39-15, Shouwa-town, Maebashi-city, Gunma
TEL
027-220-8222
asao@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Asao |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Oncology Clinical Development
Zip code
Address
3-39-15, Shouwa-town, Maebashi-city, Gunma
TEL
027-220-8222
Homepage URL
asao@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School 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
| 2014 | Year | 03 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | 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
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015617
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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