UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2009 Year 04 Month 15 Day
Date of IRB	2009 Year 04 Month 19 Day
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	2021 Year 01 Month 26 Day

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