UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II study of preoperative chemoradiotherapy with S-1, Celecoxib and Radiation for locally advanced rectal cancer
Title of the study (Brief title)	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	Hisahiro Matsubara
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
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	Gaku Ohira
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014976