UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Acronym	A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Scientific Title	A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Scientific Title:Acronym	A phase II study on the feasibility and efficacy of preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Region	Japan

Condition
Condition	rectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Feasibility and efficacy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	Response rate, overall and disease-free survival, quality of life, adverse events, postoperative complications, pathological complete response rate, and diagnostic accuracy of MRI

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	preoperative chemoradiotherapy+surgery
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	# Pathologically proven adenocarcinoma. # Primary tumor located at Upper rectum, Lower rectum, and Anal canal. The lower border of the tumor located between the peritoneal reflection and the anal verge. # cT3 and cT4a tumor with a distance of less than 2 mm between tumor and mesorectal fascia on MRI # No Lateral lymph nodes (5mm and more in short axis diameter) on MRI data # No distant metastasis on contrast-enhanced CT or MRI (cM0) # Aged 20 to 75 years old # Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 # Adequate organ function as evidenced by the following laboratory studies and symptoms within 14 days prior to enrollment 1) White blood count >= 2,000 /mm3 2) Neutrophil count >= 1,000 /mm3 3) Platelet count >= 75,000 /mm3 4) Fever <= 38.0C 5) Diarrhea=< Grade 2 (CTCAE ver.4.0) 6) Stomatitis=< Grade 2 7) Total bilirubin=< Grade 2 8) AST /ALT =< Grade 2 9) Cr =< Grade 2 # Written informed consent
Key exclusion criteria	# Distant metastases # Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year. # Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year. # Cancerous fluid on diagnostic imaging. # Prior chemotherapy or pelvic irradiation for malignancy. # Other cancer diagnosis within the past 5 years (including colorectal cancer). # Interstitial pneumonia or fibroid lung. # Uncontrolled diabetes mellitus. # Uncontrolled hypertension # Ileus (cases with diverting stoma are eligible). # Uncontrolled diarrhea. # Pregnant, nursing or no intention to contraception. # Those considered inappropriate for participation in this trial.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyotaka Okuno, MD
Organization	Kindai University Faculty of Medicine
Division name	Surgery
Zip code
Address	377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL	072-366-0221
Email	k-okuno@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Junichiro Kawamura, MD
Organization	Kindai University Faculty of Medicine
Division name	Surgery
Zip code
Address	377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL	072-366-0221
Homepage URL	http://www.kindai-geka.jp/general/endoscopic/transition.html
Email	kawamuraj@med.kindai.ac.jp

Sponsor
Institute	Department of Surgery Kindai University Faculty of Medicine
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	2016 Year 08 Month 15 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	2016 Year 06 Month 15 Day
Date of IRB	2015 Year 06 Month 24 Day
Anticipated trial start date	2016 Year 08 Month 15 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 14 Day
Last modified on	2019 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027202