UMIN-CTR Clinical Trial

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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute	Kurume University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014139

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