UMIN-CTR Clinical Trial

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

rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Maximum tolerated dose
Recommended dose

Key secondary outcomes

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

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

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

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

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

Institute

Toho University School of Medicine

Institute

Department

Personal name

Organization

Toho University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2010

Year

03

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

03

Month

25

Day

Last modified on

2014

Year

06

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004107