UMIN-CTR Clinical Trial

Public title

Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Acronym

Limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Scientific Title

Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Scientific Title:Acronym

Limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Region

Japan

Condition

Rectal cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate safety and efficacy of combination thrapy of limited Surgery with adjuvant 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

Primary outcomes

Relapse-free survival

Key secondary outcomes

Disease-free survival
Overall survival
Local relapse-free survival
Adverse events,
Anal sphincter preservation
Anal function

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 (80 mg/m2/d) 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

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 locally advanced lower rectal cancer with preoperative diagnosis of T1/2 and N0-3 and M0.
3) Tumor diameter=< 30mm
4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma
5) Has at least one of the following factors
i. Invaded the submucosa (SM)>= 1000um or muscularis propria (MP).
ii. Has venous or lympho-vessel invasion
iii. Tumor budding Grade2/3
6) Negative surgical margin
7) No prior therapy expect the operation.
8) No severe complications
9) Age :> =65 years
10) Performance status (ECOG) of 0-1
11) Capability of oral intake
12) Patients who have satisfied the following the clinical test values within two weeks before the registration.
i. WBC: 3,000-12,000 /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: >= 40 ml/min
13) 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 fluorocytosine.
6) Severe complication.
7) Pregnant or lactating woman at any time during study. Men of the fertility hope.
8) Severe mental disorder.
9) Patients judged inappropriate for the study by their physicians.

Target sample size

50

Name of lead principal investigator

1st name	Shingo
Middle name
Last name	Noura

Organization

Toyonaka Municipal Hospital

Division name

Surgery

Zip code

560-8565

Address

4-14-1 Shibaharatyou, Toyonaka, Osaka 560-8565,Japan

TEL

06-6843-0101

Email

s-noura@umin.ac.jp

Name of contact person

1st name	Norikatsu
Middle name
Last name	Miyoshi

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871,Japan

TEL

06-6879-3251

Homepage URL

Email

nmiyoshi@gesurg.med.osaka-u.ac.jp

Institute

Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka University Hospital

Address

2-15 Yamadaoka, Suita, Osaka 565-0871,Japan

Tel

06-6879-5685

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

01

Month

11

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

01

Day

Last modified on

2021

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008449