UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011417
Receipt number R000013367
Scientific Title Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer
Date of disclosure of the study information 2013/08/15
Last modified on 2013/08/08 10:57:56

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Basic information

Public title

Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer

Acronym

T1, T2 Study

Scientific Title

Local excision with postoperative chemoradiotherapy for T1, T2 rectal cancer

Scientific Title:Acronym

T1, T2 Study

Region

Japan


Condition

Condition

T1,T2 cancer of low rectum

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation on feasibility of local excision with chemoradiotherapy for T1,T2 lower rectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Disease free survival at five years

Key secondary outcomes

Overall survival at five years
Local relapse-free survival
Salvage treatment and prognosis
Adverse events in chemoradiotherapy


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 Maneuver Other

Interventions/Control_1

Local excision
Postoperative chemoradiotherapy

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. Primary rectal cancer located within lower rectum
2. Clinical T1 or T2, N0, M0
3. Tumor size within 3cm, and possible to be curative local excision
4. Without severe complications. PS(ECOG) of 0 or 1
5. Pathological proven well or moderately adenocarcinoma
6. First treatment of rectal cancer
7. Without synchronous or metachronous ( within 5 years ) malignancies
8. written informed consent
9. Aged 20 to 75 years old.
Pathological proven well or moderately adenocarcinoma in resected specimen
10. Depth of sm-massive invasion, or with lymphatic or venous vessels invasion, or depth of mp invasion
11. Pathological negative surgical margins in resected specimen
12. Enough organ functions
i. WBC count : >=3000/mm3
ii. Platelet count : >=100,000/mm3
iii. T-Bil : <=1.5mg/dl
iv. AST/ALT : <=100IU/l
v. Cr : <=1.5mg/dl
Normal ECG

Key exclusion criteria

1. Pathological proven poorly or mucinous adenocarcinoma by biopsy
2. Clinical N positive
3. Distant metastasis
4. PS (ECOG) 2, 3, and 4
5. Without written informed consent
6. Pathological proven poorly or mucinous adenocarcinoma in resected specimen
7. Pathological positive surgical margins in resected specimen
8. Depth of m invasion, or sm-minute invasion without vessels invasion
9. Bone marrow dysfunction
10. Be certain or suspicious pregnant
11. Precious radiotherapy in abdomino-pelvic area
12. Unsuitable patients for this study

Target sample size

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Saito

Organization

National Cancer Center Hospital East

Division name

Colorectal and Pelvic Surgery

Zip code


Address

6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan

TEL

04-7133-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Norio Saito

Organization

National Cancer Center Hospital East

Division name

Colorectal and Pelvic Surgery

Zip code


Address

6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

norsaito@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
愛知県がんセンター中央病院(愛知県)
山形県立中央病院(山形県)
大阪府立成人病センター(大阪府)
新潟県立がんセンター(新潟県)
石川県立中央病院(石川県)
四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
国立病院機構名古屋医療センター(愛知県)


Other administrative information

Date of disclosure of the study information

2013 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

No longer recruiting

Date of protocol fixation

2002 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2002 Year 12 Month 01 Day

Last follow-up date

2015 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 08 Day

Last modified on

2013 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name