UMIN-CTR Clinical Trial

Public title

Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer

Acronym

Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer(JFMC38-0901)

Scientific Title

Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer

Scientific Title:Acronym

Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer(JFMC38-0901)

Region

Japan

Condition

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the clinical effectiveness of UFT-PSK combination as adjuvant therapy in comparison to surgery-alone for rectal cancer.
Enrolling patients : pTNM stage II (UICC version6) rectal cancer who have undergone surgery of remaining tumor R0.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Disease-free survival

Key secondary outcomes

1) Overall survival
2) Relation between Clinical Parameters and prognosis

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Control group : surgery-alone

Interventions/Control_2

UFT : Administered orally 400 mg/day thrice daily after meal for 5 days and followed by 2 days rest (one cycle) for one year after surgery.
PSK:Administered orally 3 g/day thrice daily after meal for one year after surgery.

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)Stage II,Histologically confirmed adenocarcinoma of the rectum.
2)Patients with resection of a rectal cancer with D2 or more lymph node dissection.
3)pN0
4)Performance status:0-2
5)Patients without receiving chemotherapy, radiation exposure, rectum resection (remove the local operation), and the excision of the pelvis lymph node ,including the treatment for the other carcinoma.
6)Patients who have satisfied the following the latest clinical test values in two weeks or after operation and within two weeks before the registration.
1.WBC:>= 3,000/mm3, <12,000/mm3
2.Neutrophile:>= 1,500/mm3
3.Hemoglobin:>= 9.0g/dL
4.Platelet:>= 100,000/mm3
5.Total bilirubin:< 1.5 mg/dL
6.AST,ALT:<100IU/L
7.Serum creatinine:<1.5mg/dL
7)Patient with starting the chemotherapy within 8 weeks after operation.
8)Patients who have given consent to participate in this clinical study by himself/herself.

Key exclusion criteria

1)Ingestion impossibility or digestive organs stricture.
2)Serious coexisting illness.
3)Primary tumor in Proctos(P) or External skin (E).
4)Active synchronous or metachronous malignancy carcinoma in situ.
5)Pregnant or nursing.
6)Not suitable for participating in the study for any other reason.

Target sample size

540

Name of lead principal investigator

1st name
Middle name
Last name	Kiyotaka Okuno

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code

Address

377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Division name

Office

Zip code

Address

TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan

TEL

03-5627-7594

Homepage URL

http://www.jfmc.or.jp/

Email

jfmc-dc@jfmc.or.jp

Institute

Japanese Foundation for Multidisciplinary Treatment of Cancer

Institute

Department

Personal name

Organization

Japanese Foundation for Multidisciplinary Treatment of Cancer

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

01

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://dx.doi.org/10.1007/s00280-017-3466-7

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

Completed

Date of protocol fixation

2008

Year

10

Month

04

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2016

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

11

Month

26

Day

Last modified on

2017

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001843