UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013486
Receipt number R000015749
Scientific Title Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer
Date of disclosure of the study information 2014/03/24
Last modified on 2021/09/10 15:57:05

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Basic information

Public title

Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer

Acronym

Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer

Scientific Title

Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer

Scientific Title:Acronym

Preoperative chemoradiotherapy with S-1 for locally advanced rectal cancer

Region

Japan


Condition

Condition

Locally advanced rectal cancer
Locally advanced anal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with S-1 in patients with locally advanced rectal cancer.

Basic objectives2

Others

Basic objectives -Others

To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for tumor regression

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pathological Complete Response rate
Predictive value for tumor regression

Key secondary outcomes

Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence
Safety


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

S-1(80mg/m2/day1-5,8-12,22-26,29-33)
Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)

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) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III.
(2) Histologically confirmed adenocarcinoma
(3) Without prior anti-tumor therapy
(4) Age:20-80years old
(5) Performance status 0-2
(6) Adequate organ function
WBC>= 4,000 <= 15,000/mm3
neutro>= 2,000/mm3
Plt>= 100,000/mm3
Hb>= 8.0g/dl
Cr<= 1.5mg/dl
T-Bil<= 1.5mg/dl
AST, ALT<= double of the upper limit
(7) Written IC with date

Key exclusion criteria

Patients judged inappropriate for this study by the physicians

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Hase

Organization

National Defense Medical College

Division name

Surgery

Zip code


Address

3-2 Namiki Tokorozawa Saitama

TEL

04-2995-1511

Email

shinto@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Shinto

Organization

National Defense Medical College

Division name

Surgery

Zip code


Address

3-2 Namiki Tokorozawa Saitama

TEL

04-2995-1511

Homepage URL


Email

shinto@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Defense Medical College

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Self-Defense Forces Central Hospital

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

2014 Year 03 Month 24 Day


Related information

URL releasing protocol

https://academic.oup.com/bjsopen/article/4/2/301/6061323

Publication of results

Partially published


Result

URL related to results and publications

https://academic.oup.com/bjsopen/article/4/2/301/6061323

Number of participants that the trial has enrolled

49

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

Main results already published

Date of protocol fixation

2014 Year 02 Month 26 Day

Date of IRB

2014 Year 02 Month 26 Day

Anticipated trial start date

2014 Year 02 Month 26 Day

Last follow-up date

2023 Year 12 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

2014 Year 03 Month 23 Day

Last modified on

2021 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name