UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012099
Receipt number R000014139
Scientific Title Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer
Date of disclosure of the study information 2013/10/22
Last modified on 2013/10/22 16:09:58

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Basic information

Public title

Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer

Acronym

Randomized Phase II Study of Antineoplastons as an Adjuvant Therapy for Liver Metastases from Colorectal Cancer

Scientific Title

Randomized Phase II Study of 5-fluorouracil Hepatic Arterial Infusion With or Without Antineoplastons as an Adjuvant Therapy After Hepatectomy for Liver Metastases from Colorectal Cancer

Scientific Title:Acronym

Randomized Phase II Study of Antineoplastons as an Adjuvant Therapy for Liver Metastases from Colorectal Cancer

Region

Japan


Condition

Condition

Liver Metastases from Colorectal Cancer

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This randomized phase II study compared the efficacy of hepatic arterial infusion (HAI) with 5-fluorouracil (5-FU), with or without antineoplastons as a postoperative adjuvant therapy for colorectal metastasis to the liver.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The primary objective was to determine whether systemic administration of antineoplastons added to adjuvant 5-FU HAI after liver resection increased cause-specific survival (CSS).

Key secondary outcomes

Secondary endpoints were evaluation of relapse-free survival (RFS), grade of recurrence and toxicity.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

In both the AN arm and the control arm, patients received HAI with 5-FU at a dose of 1000 mg/m2 for 4 hours weekly or biweekly until the cumulative dose reached up to 15,000 mg.

Interventions/Control_2

In the AN arm, a starting dose of 30 g/day of A10-I was administered intravenously (i.v.) using a pump system with maximum dose of 100 g/day for more than 3 days. After completion of the i.v. administration of A10-I for a week, 10 g/day of AS2-1 was administered orally for 1 year.
Patients in the control group receive no antineoplastons.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Eligible patients had histologically confirmed metastatic colorectal adenocarcinoma to the liver. Patients were treated with R0 resection of liver metastases and/or complete ablation by radio frequency interstitial ablation therapy between April 1998 and August 2004 at Kurume University Hospital. The inclusion criteria were age <75 years, no severe major organ dysfunction, no prior cancer therapy to the liver, no extra-hepatic metastases at study entry, Eastern Cooperative Oncology Group (ECOG) performance status 2, no other malignancy (within the 5 years prior to study entry), white blood cell count >=3000/&micro;L, absolute neutrophil count >=1500/&micro;L, platelet count >=75,000/&micro;L, total bilirubin <2.0 mg/Dl and serum creatinine <2.0. Computed tomography (CT) scans of the chest, abdomen, and pelvis were required to have been carried out within the 6 weeks prior to protocol registration. All patients provided signed informed consent after hepatectomy

Key exclusion criteria

1)No treatment with chemotherapeutics and radiation
2)Simultaneous or metachronous double cancers
3)Pregnant or lactating women or women of childbearing potential
4)Other patients who are unfit for the study as determined by the attending physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Shirouzu

Organization

Kurume University School of Medicine

Division name

Department of Surgery

Zip code


Address

67 Asahi-machi, Kurume 830-0011, Japan

TEL

0942-35-3311

Email

drkshorouzu@ktarn.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Ogata

Organization

Kurume University Medical Center

Division name

Department of Surgery

Zip code


Address

155-1 Kokubu-machi, Kurume 839-0863, Japan

TEL

0921-22-6111

Homepage URL


Email

yogata@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

2013 Year 10 Month 22 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

Completed

Date of protocol fixation

1998 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

1998 Year 04 Month 01 Day

Last follow-up date

2012 Year 08 Month 01 Day

Date of closure to data entry

2012 Year 08 Month 01 Day

Date trial data considered complete

2012 Year 12 Month 01 Day

Date analysis concluded

2012 Year 12 Month 01 Day


Other

Other related information

This work was presented as an abstract at the EMSO conference in 2010.


Management information

Registered date

2013 Year 10 Month 22 Day

Last modified on

2013 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name