UMIN-CTR Clinical Trial

Basic information
Public title	Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Acronym	Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Scientific Title	Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Scientific Title:Acronym	Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Region	Japan

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

Objectives
Narrative objectives1	To investigate safety and efficacy of combination therapy of limited Surgery with neoadjuvant chemoradiotherapy for T1 or T2 lower rectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Relapse-free survival Disease-free survival Overall survival Local relapse-free survival Adverse events Anal sphincter preservation Anal function

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	Xeloda was given orally after breakfast and dinner on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33. Radiotherapy was administered in fractions of 1.8 Gy/d, given 5 days per week for 5 weeks. The total dose of radiation was 45 Gy.
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) Main part of the tumor is located in P-Rb. 2) Previously untreated lower rectal cancer with preoperative diagnosis of T1/2 and N0 and M0. 3) Tumor diameter=< 30mm. 4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma. 5) No prior therapy expect the operation. 6) No severe complications 7) Age >= 20 years 8) Performance status (ECOG) of 0-1 9) Capability of oral intake 10) Patients who have satisfied the following the clinical test values within two weeks before the registration. i. WBC: 3,500-12,000 /mm3 ii. Neutrophile >= 1,500/mm3 iii. Platelet > = 100,000/mm3 iv. Hemoglobin > = 9.0g/dL v. Total bilirubin =< 2.0 mg/dL vi. AST =< 100IU/L vii. ALT =< 100IU/L viii. Ccr >= 30 ml/min 11) Written informed consent.
Key exclusion criteria	1) Active synchronous or metachronous malignancy carcinoma in situ. 2) Non-treated radiotherapy 3) Medical history of severe anaphylaxis or allergia to any drug. 4) Severe diarrhea. 5) Undergoing treatment with Tegafur, Gimeracil, Oteracil Potassium. 6) Undergoing treatment with Warfarin Potassium, Phenytoin, Trifluridine, Tipiracil Hydrochloride. 7) Severe complication. 8) Pregnant or lactating woman at any time during study. Men of the fertility hope. 9) Severe mental disorder. 10) Patients judged inappropriate for the study by their physicians.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hasegawa Middle name Last name Junichi
Organization	Osaka Rosai Hospital
Division name	Department of Surgery
Zip code	591-8025
Address	1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
TEL	072-252-3561
Email	j-hasegawa@osakah.johas.go.jp

Public contact
Name of contact person	1st name Sueda Middle name Last name Toshinori
Organization	Osaka Rosai Hospital
Division name	Department of Surgery
Zip code	591-8025
Address	1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
TEL	072-252-3561
Homepage URL
Email	tsueda@osakah.johas.go.jp

Sponsor
Institute	Osaka Rosai Hospital
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	Osaka Rosai Hospital
Address	1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
Tel	072-252-3561
Email	tsueda@osakah.johas.go.jp

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	2019 Year 06 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 05 Day
Date of IRB	2018 Year 03 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 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	2019 Year 06 Month 07 Day
Last modified on	2019 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041894