UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000996
Receipt number R000001199
Scientific Title A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer
Date of disclosure of the study information 2008/01/25
Last modified on 2015/04/18 09:01:34

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Basic information

Public title

A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer

Acronym

A phase II study of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer

Scientific Title

A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer

Scientific Title:Acronym

A phase II study of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer

Region

Japan


Condition

Condition

liver metastases of colorectal cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine safety and efficacy of modified FOLFOX-6 as adjuvant treatment after resection of liver metastases from colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

disease free
survival side effect

Key secondary outcomes

overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2 weeks] for 24 weeks as adjuvant treatment after resection of liver metastases from colorectal cancer.

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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) First treatment for metastatic liver tumors of colorectal cancer (2) Histologically confirmed metastatic liver tumors of colorectal cancer (3) R0 and R1 after resection of both primary and metastatic tumors (4) No extrahepatic tumors (5) Performance status is 0-2 (6) Function of main organs is kept as below. WBC is from lower normal limit to 12,000/mm3. Neutrophil is over 1,500/mm3. Platet is over 100,000/mm3. Hb is over 9.0/dL. Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 2.5 times of normal limits. ALP is within 2.5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent

Key exclusion criteria

(1) Multiple cancer (2) Prebious history of severe drug-induced allergy (3) Given L-OHP within 6 months before this study (4) Active infection (5) Severe complication (6) Severe sensory disturbance (7) Pregnant (8) Disqualified by attendig doctor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiaki Unno

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Hepato-Biliary Pancreatic Surgery

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN

TEL

022-717-7208

Email

kein_h11@surg1.med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kuniharu Yamamoto

Organization

Miyagi HBPCOG coordinating office

Division name

Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.

Zip code


Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN

TEL

022-717-7208

Homepage URL


Email

kyama@surg1.med.tohoku.ac.jp


Sponsor or person

Institute

Miyagi HBPCOG

Institute

Department

Personal name



Funding Source

Organization

Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.

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



Other administrative information

Date of disclosure of the study information

2008 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2006 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2006 Year 07 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry

2014 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 04 Month 01 Day

Date analysis concluded

2014 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 01 Month 25 Day

Last modified on

2015 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001199


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name