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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003382
Receipt No. R000004107
Scientific Title Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer
Date of disclosure of the study information 2010/03/26
Last modified on 2014/06/04

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Basic information
Public title Phase 1 trial of neoadjuvant
chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer
Acronym Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer
Scientific Title Phase 1 trial of neoadjuvant
chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer
Scientific Title:Acronym Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with 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 feasibility and efficacy of preoperative radiation with TS-1 in patients with locally advance rectal cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum tolerated dose
Recommended dose
Key secondary outcomes

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 TS-1:Level1 50mg/m2,
Level2 65mg/m2,Level3 80mg/m2
day1-5,8-12,15-19,22-26,29-33
Radiation:1.8Gy of consecutive 5days,
Total dose 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed low Rectum adenocarcinoma(without Rs)
2.Preoperative CT or MRI findings
the clinical stage is T3-4 and any N
3.Main lesion of the tumor is located at the Ra or Rb.
4.Recectable
5.No evidence of peritoneal
metastasis, liver metastasis and
distant metastasis.
6.age:20-80years old
7.Performance status 0-1
8.Without prior anti-tumor therapy
9. Adequate organ function
10.the case can eat
11.Written IC
Key exclusion criteria 1.Impossible to receive TS-1 contained chemotherapy
2.Recieving the radiation therapy in a pelvis
3.Infection
4.Serious complications
5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug
6.Multiple malignancies
7. Pleural effusion or ascites requiring
8.Current or previous Brain
metastasis
9.Diarrhea(watery stool)
10.Fresh bleeding of digestive organs
11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin
12.Evidence of psychiatric disability interfering with enrollment to clinical trial
13.Pregnant or lactating women,
women who are capable of pregnancy or intend to get pregnant
14.Man of wanting child
15.Need Systemically administration of corticosteroids
16.Patients judged inappropriate for this study by the physicians
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimihiko Funahashi
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL 03-3762-4151
Email kingkong@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimihiko Funahashi
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL 03-3762-4151
Homepage URL
Email kingkong@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine
Institute
Department

Funding Source
Organization Toho University School of Medicine
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
2010 Year 03 Month 26 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
All patients achieved the planned 45 gray of radiation therapy
There was no grade 3 toxicity
The recommended dose of S-1 was determined to be 80 mg/day
The dose intensity of S-1 was well maintained and the combination of S-1 plus radiation therapy was well tolerated by all patients
Sphincter preserving procedures were possible in all but one (89%) patient
High rates of tumor shrinkage and nodular downstaging were achieved
The histological response rate was 78% including one complete response
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
2010 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 25 Day
Last modified on
2014 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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