UMIN-CTR Clinical Trial

Public title

Multicentral phase II study of adjuvant UFT/LV chemotherapy with completely resected rectal cancer.

Acronym

SISCO-RC 01

Scientific Title

Multicentral phase II study of adjuvant UFT/LV chemotherapy with completely resected rectal cancer.

Scientific Title:Acronym

SISCO-RC 01

Region

Japan

Condition

Rectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy and safety of adjuvant adjuvant UFT/LV chemotherapy with completely resected rectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

3y RFS

Key secondary outcomes

OS, Safety, treatment completion rate

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

UFT (300mg/m2/day) and UZEL (75mg/day) will be applied for patients with Stage II and III rectal cancer (Ra and Rb) who underwent curative resection for 28 days and these drugs will be stopped following 7 days. These 35 days will be one course. And total 5 courses of UFT/UZEL will be applied for the patients.

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)Histopathologically confirmed rectal cancer (Ra, Rb)
2)Patient who has received surgery with D2 or more lymph node dissection and whose final curability A (R0)
3)Stage II / III
4)No hepatic, peritoneal, or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis
5)Age>20.
6)No previous treatment(radiation therapy, chemotherapy, hormone therapy) for cancer except for surgical treatment.
7)Oral administration is possible within 8 weeks after surgical treatment.
8)Without any other severe diseases and adequate organ functions.
Leu: >=4,000 /mm3, <=ULN
Plt: >= 100,000 /mm3
T-bil: < 1.5 g/dL
ALT: <=ULNx2.5
AST: <=ULNx2.5
Serum creatinine: <ULN
Ccr: >= 30 mg/min
9)With written informed consent

Key exclusion criteria

1)Patients with severe surgical complication.
2)Phenytoin, warfarin potassium, or flucytosin administration.
3)Allergic more than and equal to grade3.
4)Patients with significant complications.
5)History of serious allergic reaction with UFT.
6)Lactating, pregnant or possibly pregnant women, and men who have willing to become partner's pregnant.
7)Patients with HIV,HBV.
8)Not appropriate for the study at the physician's assessment.

Target sample size

65

Name of lead principal investigator

1st name
Middle name
Last name	Masahide Ikeguchi

Organization

Tottori University

Division name

Division of Surgical Oncology

Zip code

Address

Nishi-cho 36-1, Yonago 683-8504, Japan

TEL

0859-38-6567

Email

masaike@med.tottori-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Keigo Ashida

Organization

Tottori University

Division name

Division of Surgical Oncology

Zip code

Address

Nishi-cho 36-1, Yonago 683-8504, Japan

TEL

0859-38-6567

Homepage URL

http://www.med.tottori-u.ac.jp/surgonco/

Email

k.ashida@med.tottori-u.ac.jp

Institute

Division of Surgical Oncology, Department of Surgery, Faculty of Medicine, Tottori University

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

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

公立八鹿病院（兵庫県）、鳥取大学医学部附属病院（鳥取県）、鳥取県立中央病院（鳥取県）、鳥取赤十字病院（鳥取県）、鳥取市立病院（鳥取県）、鳥取生協病院（鳥取県）、鳥取県立厚生病院（鳥取県）、山陰労災病院（鳥取県）、米子医療センター（鳥取県）、医療法人十字会野島病院（鳥取県）、医療法人同愛会博愛病院（鳥取県）、浜田医療センター（島根県）、松江市立病院（島根県）、松江生協病院（島根県）、益田赤十字病院（島根県）、済生会江津総合病院（島根県）、益田地域医療センター医師会病院（島根県）、西伯病院（鳥取県）、日野病院（鳥取県）

Date of disclosure of the study information

2013

Year

11

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

Open public recruiting

Date of protocol fixation

2011

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

08

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

2013

Year

10

Month

03

Day

Last modified on

2013

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013923