UMIN-CTR Clinical Trial

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

Colorectal Cancer

Classification by specialty

Hematology and clinical oncology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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 3,000/mm3 and 12,000/mm3.
b. neutrophil count 1,500/mm3.
c. platelet count 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

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

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

Institute

NPO Epidemiological and Clinical Research Information Network (ECRIN)

Institute

Department

Personal name

Organization

NPO Epidemiological and Clinical Research Information Network

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

07

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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