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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002211
Receipt No. R000002710
Scientific Title Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)
Date of disclosure of the study information 2009/07/16
Last modified on 2009/07/16

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Basic information
Public title Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)
Acronym Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: Randomized Phase II study (The GONE Study)
Scientific Title Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)
Scientific Title:Acronym Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: Randomized Phase II study (The GONE Study)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The GONE study is a double-blind, randomized, placebo-controlled, multicenter phase II trial that is performed in adult patients with advanced/recurrent colorectal cancer in order to investigate the preventive effect of GJG for peripheral neurotoxicity induced by L-OHP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy.
Key secondary outcomes the incidence of each grade of peripheral neurotoxicity after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate, and toxicity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred.
Goshajinkigan(GJG) is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion.
Interventions/Control_2 FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred.
Placebo is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria
i. Histologically confirmed colorectal cancer.
ii. No prior chemotherapy. However, patients with recurrence more than 4 weeks after completion of adjuvant chemotherapy with an oral pyrimidine fluoride derivative or 5-FU/l-LV were also eligible.
iii. ECOG P.S. of 0 or 1.
iv. Age of at least 20 years at registration.
v. A life expectancy of more than 12 weeks.
vi. Adequate function of vital organs, including normal hematopoietic function, normal liver function, and normal renal function as evidenced by the following data within 7 days before registration:
a. white blood cell count &#61619;3,000/mm3 and &#61603;12,000/mm3.
b. neutrophil count &#61619;1,500/mm3.
c. platelet count &#61619;100,000/mm3.
d. aspartate aminotransferase and alanine aminotransferase levels less than 2.5 times the institutional upper limit of normal.
e. total bilirubin level less than 1.5 times the institutional upper limit of normal.
f. serum creatinine level below the institutional upper limit of normal.
vii. All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria
i. Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration.
ii. Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration.
iii. History of severe hypersensitivity (allergy) to any medicines.
iv. Prior or current therapy for neuropathy or sensory dysfunction.
v. Other active malignancies or a history of other malignancies within the past five years.
vi. Uncontrolled pleural effusion or ascites.
vii. Pericardial effusion.
viii. A systemic inflammatory condition or serious infection.
ix. Symptomatic brain metastasis.
x. Significant electrocardiographic abnormality.
xi. Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months).
xii. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.).
xiii. Gastrointestinal bleeding that requires medication or transfusion.
xiv. Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma.
xv. Ileus or bowel obstruction.
xvi. Central nervous system disorders.
xvii. Senile dementia.
xviii. Serious psychological disease.
xix. Uncontrolled diabetes mellitus with or without diabetic neuropathy.
xx. Pregnant or lactating women.
xxi. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kono
Organization Asahikawa Medical College
Division name Gastroeneterologic and general surgery
Zip code
Address 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-65-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Kono
Organization Asahikawa Medical College
Division name Gastroeneterologic and general surgery
Zip code
Address 2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-65-2111
Homepage URL
Email kono@asahikawa-med.ac.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization NPO Epidemiological and Clinical Research Information Network
Organization
Division
Category of Funding Organization Other
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
2009 Year 07 Month 16 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 No longer recruiting
Date of protocol fixation
2009 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 16 Day
Last modified on
2009 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002710

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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