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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012099
Receipt No. 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

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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
Institute Kurume University School of Medicine
Institute
Department

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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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