UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010980
Receipt number R000012856
Scientific Title Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer
Date of disclosure of the study information 2013/06/18
Last modified on 2013/06/17 15:52:36

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Basic information

Public title

Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer

Acronym

HORE CC01

Scientific Title

Randomized phase II study with UFT capsule /LV or UFT E-granule /LV adjuvant chemotherapy for patients with completely resected high-risk stage II and III colorectal cancer

Scientific Title:Acronym

HORE CC01

Region

Japan


Condition

Condition

colorecrtal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the clinical effectiveness of the UFT/LV for the patients with Stage II with risk factors of recurrence and III colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

treatment complete rate

Key secondary outcomes

Safety, Dose Intensity, QOL(EORTC QLQ-C30), Relapse free survival,overall survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

UFT capsule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).

Interventions/Control_2

UFT E-granule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed Colorectal cancer
2)high-risk Stage II-III
3) Performance Status (ECOG) 0-1
4) more than 20 years old
5) hasn't received any treatment other than R0 resection.
6) can start the therapy within 8 weeks after surgery.
7) Adequate organ functions
8) Oral intake is possible
9) Written informed consent

Key exclusion criteria

A patient:
1)with administration contraindications for UFT,LV.
2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years).
3)has severe postoperative complications such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding.
4) has severe diarrhea.
5)has severe drug hypersensitivity.
6)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant.
7)with psychosis or psychoneurosis.
8)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Konno

Organization

Hamamatsu University School of Medicine

Division name

Second Department of Surgery

Zip code


Address

1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiyotaka Kurachi

Organization

Hamamatsu University School of Medicine

Division name

Second Department of Surgery

Zip code


Address

1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan

TEL

053-435-2279

Homepage URL


Email



Sponsor or person

Institute

HORE

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

磐田市立総合病院
浜松医療センター
静岡市立清水病院
松愛会 松田病院


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 17 Day

Last modified on

2013 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name