UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000012818
Receipt number	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 20:40:30

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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

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

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

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

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 or person

Institute

Department of frontier surgery Graduate school of medicine, Chiba University

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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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