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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012818
Receipt No. R000014976
Scientific Title A phase I/II study of preoperative chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Date of disclosure of the study information 2014/01/10
Last modified on 2017/07/28

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Basic information
Public title A phase I/II study of preoperative chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Acronym chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Scientific Title A phase I/II study of preoperative chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Scientific Title:Acronym chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to establish the efficacy and feasibility of preoperative radiotherapy with concurrent S-1 and Celecoxib in patients with rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes MTD and RD are determined by Phase I part. Histopathological effect are primary endpoint of Phase II part.
Key secondary outcomes Phase I part: Histopathological effect

Phase II part: Response rate, Progression-free survival, Overall survival, Rate of adverse events, R0 resection, sphincter preserving, Down Staging,
value of COX2 expression for tumor regression

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 Radiotherapy with fractions of 1.8 Gy/day, given 5 days per week for 25days. The total dose of radiation will be 45 Gy.
S-1 will be given orally two times per day on Days 1-5, 8-12, 15-19, 22-26, 29-33. Celecoxib will be given orally two times per Days with enforcementing an irradiation date.
Radical surgery will be performed less than eight weeks six or more-week after the completion of neoadjuvant chemoradiotherapy.
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). Histopathologically confirmed as rectal cancer (adenocarcinoma)
2). diagnosed as partial advance lower rectal cancer (adenocarcinoma)
3). without distant metastases
4). Clinical stage T3 or T4, and/or lymph node positive.
5). treatment is not enforced before the radiation exposure in chemotherapy or the pelvis from head to foot.
6). Age at the time of the registration is a case 20 years or older
7). Eastern Cooperative Oncology Group performance status 0-1
8). more than three months than the treatment starting date is expected
9). a main organ (marrow, lungs, liver, kidney) does not have a high obstacle
10). organ functions are secured for less than 14 days before registration by inspection of (possible as for the inspection of the same day two weeks before the registration day)
(1) leukocytes: Less than more than 4,000 /mm3 and 12,000 /mm3
(2) neutrophils: More than 2,000 /mm3
(3) platelets: More than 100,000 /mm3
(4) haemoglobin: More than 9.0 g/dL
(5) AST(GOT)/ALT(GPT): 100IU/L or less
(6) total bilirubin: Lower than 1.5 mg/dL
(7) creatinine clearance: More than 60 mL/min
11). Ability to ingestion intake and drug administration orally.
12). Informed consent is obtained.
Key exclusion criteria 1). Even if is an overlap cancer case of the activity or heterochrony; a treatment-free and disease-free period the case (but cancer in the epithelium and the skin cancer are excluded) less than five years
2). It is a case with a history of the radiation therapy including the irradiation after art for a lesion
3). with the diarrhea (water-like flight)
4). receiving flucytosine
5). It is a case with the past of hypersensitivity for S-1, an ingredient of celecoxib
6). The case (diabetes having poor heart, kidney, liver failure, control) with serious complications
7). Aspirin asthma or a case with the past
8). with peptic ulcer of the activity
9). uses an NSAID regularly
10). hydrothorax, abdominal dropsy to need urgent treatment
11). having an infectious disease of the activity few for tumor in itself
12). having the intestinal tract paralysis, ileus
13). with the possibility (intention) of the pregnancy, a pregnant woman or a nursing girl, a case without the intention to prevent conception
14). A perioperative patient of the coronary bypass rebuilding art
15). In addition, the case that I judged to be inappropriate though the examination medical attendant carried out the final examination safely
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Graduate school of medicine, Chiba University
Division name Department of frontier surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL 043-226-2110
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gaku Ohira
Organization Graduate school of medicine, Chiba University
Division name Department of frontier surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL 043-226-2110
Homepage URL
Email Ohira@faculty.chiba-u.jp

Sponsor
Institute Department of frontier surgery Graduate school of medicine, Chiba University
Institute
Department

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
Email

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 01 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 Completed
Date of protocol fixation
2013 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 29 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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