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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Liver Metastases from Colorectal Cancer | ||
Classification by specialty |
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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 |
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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. |
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Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
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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 |
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Age-upper limit |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
Other related information | This work was presented as an abstract at the EMSO conference in 2010. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014139 |