UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002211
Receipt number 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 2021/01/26 17:56:56

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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 or person

Institute

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Institute

Department

Personal name



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

Value
https://center6.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