UMIN-CTR Clinical Trial

Public title

Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer

Acronym

Phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer

Scientific Title

Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer

Scientific Title:Acronym

Phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer

Region

Japan

Condition

Rectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We perform phase I trial to research recommended dose and safety of UFT for the operable T3 and T2N1-2 rectum cancer in the UFT/LV medical treatment and radiotherapy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

The decision of maximal tolerated dose (MTD) and recommended dose (RD) of UFT
Safety (the degree and grade of the adverse event and the surgical complication)

Key secondary outcomes

Antitumor effect (objective response rate)
The rate of pathological CR

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

Chemotherapy:
UFT:240, 300 mg/m2/day
LV:75 mg/body/day Day 1-28
Radiotherapy:
1.8 Gy/day, Day 1-5 every 7 days, 25 times, total 45Gy

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) The case of T3 and T2N1-2 rectum cancer proved for histopathology (Besides Rs)
(2) The first time chemotherapy case
(3) The case without the past of the radiation therapy
(4) The case without the high obstacle for the marrow, the liver, the kidney and cardiac function(judging from the laboratory data within 14 days before registration)
(5) The case without the ileus
(6) The case performance status (ECOG) is 0-1
(7) The case that survival time is expected to be more than three months from a treatment start day
(8) Age at the time of the consent acquisition is over 20 years old.
(9) Written informed consent

Key exclusion criteria

(1) The case with a serious myelosuppression
(2) The case that it is clear to have pneumonitis, pulmonary fibrosis with a chest x-ray film, or the case having these anamneses
(3) The pleural or pericardial effusion requiring drainage (The case to need tube drainage or waste fluid by the puncture)
(4) The case with the double cancer (The cancer in the epithelium and the skin cancer are removed.)
(5) The infectious disease, the intestinal paralysis and the ileus
(6) Diarrhea (water-like mail)
(7) It is during treatment or a control poor diabetes case by continuous use of the insulin
(8) The case having a complication (heart failure, liver failure, renal failure)
(9) The brain metastasis case of the existence symptom
(10) The pregnant or nursing patients and patients who may be a pregnant
(11) The case with having experienced serious drug allergy in the past
(12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Kamigaki

Organization

Kobe University Graduate School of Medicine

Division name

Division of Gastrointestinal Surgery

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo

TEL

078-382-5925

Email

Name of contact person

1st name
Middle name
Last name	Takashi Kamigaki

Organization

Kobe University Graduate School of Medicine

Division name

Division of Gastrointestinal Surgery

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo

TEL

078-382-5925

Homepage URL

http://www.med.kobe-u.ac.jp/surg1/index.html

Email

Institute

Division of Gastrointestinal Surgery,
Kobe University Hospital

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

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

2009

Year

05

Month

19

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

2009

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2011

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

05

Month

19

Day

Last modified on

2010

Year

01

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002419