UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of the preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer aiming at sphincter preservation.
Title of the study (Brief title)	The preoperative chemoradiotherapy for T3-4, N0-N2 rectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of UFT/LV+radiation of concurrent neo-adjuvant chemoradiotherapy for patleuts with T3-4 N0-2 rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Accomplishment rate of sphincter-preserving surgery with mesorectal excision.
Key secondary outcomes	1. Incidence of adverse events, surgical morbidity and mortality and postoperative QOL. 2. Macroscopic and pathological evaluation of primary lesion 3. Histological change of normal tissue in resected specimen 4. Disease free survival (DFS) and overall survival (OS)

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	Radiation2.0 Gy/day 25 times (5 weeks), total radiation 50Gy. Consisting of 5 weeks and 5 consecutive days of radiation followed by 2 days off. UFT 300mg/m2 and LV 75mg/day orally daily on days 1-5 rest 2 days every week for 5 weeks.
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	1. Age:20-75 years old 2. Performance status(ECOG):0-2 3. Histopathological confirmation of wel or mod adenocarcinoma 4. The main site the tumor is occupying is Ra or Rb 5. No metastasis of lymph node without region lymph node 6. Sufficient organs functions 7. No prior treatment for rectal cancer 8. Written informed consent
Key exclusion criteria	1. Patients with severe organ disfunction 2. Patients with uncontrollable ascites and pleural effusion 3. Patients with gastrointestinal bleeding 4. Patients with severe infection 5. Patients with severe complications 6. Synchronous or metachronous malignancy 7. Patients who have undergone abdominal radiotherapy 8. Patients with severe mental disorders 9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. 10. Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size	28

Research contact person
Name of lead principal investigator	Hideyuki Ishida
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Digestive Tract and General Surgery
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	048-228-3619
Email	05hishi@saitama-med.ac.jp

Public contact
Name of contact person	Hideyuki Ishida
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Digestive Tract and General Surgery
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	049-228-3619
Homepage URL
Email	05hishi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
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	2012 Year 11 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 11 Month 29 Day
Last modified on	2017 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011084