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/µL, absolute neutrophil count >=1500/µL, platelet count >=75,000/µL, 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
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
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
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
