UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006242 |
|---|---|
| Receipt number | R000007384 |
| Scientific Title | A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer. |
| Date of disclosure of the study information | 2011/08/28 |
| Last modified on | 2011/08/28 18:53:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer.
Acronym
A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer. (PRESENTER)
Scientific Title
A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer.
Scientific Title:Acronym
A Phase II study of preoperative concurrent chemoradiotherapy with TS-1 in patients with locally advanced lower rectal cancer. (PRESENTER)
Region
| Japan |
Condition
Condition
Locally-advanced lower rectal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of S-1/Radiation of concurrent neo-adjuvant therapy of locally-advanced and recurrent lower rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Histological response evaluation
Key secondary outcomes
Tumor regression grading
Accomplishment rate
Response rate
Progression free survival
Overall survival
Incidence and degree of adverse events
R0-resection rate
Sphincter preservation
Down Staging rate
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
Radiation 1.8Gy/day 25 times(5 weeks)
Total radiation 45Gy.
Consisting of 5 weeks and 5 consecutive days of radiation followed by 2 days off.
TS-1
80-120 mg/m2 orally twice daily on days 1-14 every 21 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histopathological confirmation of lower rectal cancer(Adenocarcinoma)
(2) locally-advanced and recurrent lower rectal cancer.
(3) Distant metastasis
(4) No prior chemotherapy
(5) Over age 20
(6) ECOG performance status of 0,1
(7) Life expectancy more than 3 months
(8) A good condition of important organs
(9) Sufficient organ functions
(10) Oral administration is possible
(11) Written informed consent
Key exclusion criteria
(1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.)
(2) Patients who have undergone radiotherapy
(3) Patients with diarrhea
(4) Patient with regular use of furucytocin
(5) Patients with severe complications,(severe cardiovascular disease,severe heart disease,heart failure,liver failure,renal failure or uncontrollable diabetes mellitus)
(6) Patients with uncontrollable ascites and pleural effusion
(7) The case suspected of infection with feaver (over 38 centigrade).
(8) Serious drug hypersensitivity
(9) Patients with paralytic ileus, bowel obstruction
(10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding.
(11) Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Kitani |
Organization
Nara Hospital Kinki University Faculty of Medicine
Division name
Surgery
Zip code
Address
1248-1 Otodachou, Ikomasi, Nara, Japan
TEL
0743-77-0880
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Kitani |
Organization
Nara Hospital Kinki University Faculty of Medicine
Division name
Surgery
Zip code
Address
1248-1 Otodachou, Ikomasi, Nara, Japan
TEL
0743-77-0880
Homepage URL
Sponsor or person
Institute
Nara Hospital Kinki 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
| 2011 | Year | 08 | Month | 28 | 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
| 2011 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 28 | Day |
Last modified on
| 2011 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007384
