UMIN-CTR Clinical Trial

Public title

Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer

Acronym

FACOS

Scientific Title

Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer

Scientific Title:Acronym

FACOS

Region

Japan

Condition

Colon cancer

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy and safety of mFOLFOX6/XELOX regimen for patients with curatively resected stage III colon cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

3-year disease-free survival

Key secondary outcomes

Safety
2-year disease-free survival
5-year median survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Gene

Interventions/Control_1

mFOLFOX6(L-OHP:85mg/m2, l-LV:200mg/m2, 5FU:400mg/m2 (bolus), 5FU:2,400mg/m2 (civ)).
Cycles of chemotherapy are given every 2 weeks for 6 months.
XELOX(Capecitabine:2000mg/m2,Oxaliplatin:130mg/m2).
Cycles of chemotherapy are given every 2 weeks for 6 months.

Interventions/Control_2

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Stage III colon and rectosigmoid cancer.
2.Colectomy with D2<= Lymph node dissection.
3.Resection of histological curability A was performed.
4.20-75 years old.
5.Performance Status(ECOG):0 or 1
6.Without prior anti-tumor therapy (chemotherapy and radiotherapy).
7.Adequate functions of bone marrow, liver and renal as belowes:
WBC>= 4,000/mm3 to =<12,000mm3.
Neutrophil >= 2,000/m m3.
Platlet is >= 100,000/m m3.
Hemoglobin >= 9.0g/dL.
AST and ALT =< 100IU/L.
Creatinine is within normal limits.
8.Able to start therapy between 4 and 8 weeks after surgery.
9.Written Informed Consent.

Key exclusion criteria

1.Synchronous multiple cancer and metachronous multiple cancer within 5-years.
2.Severe postoperative complications
,such as infection, ruptured suture, gastrointestinal bleeding.
3.Sensory peripheral neuropathy.
4.Uncontrolled hypertension.
5.Uncontrolled Diabetes Mellitus.
6.Marked abnormality of ECG, or clinically important cardiac disorders such as congestive heart failure, symptomatic coronary artery disease, uncontrolled arrythmia,history of cardiac infarction within 12 months.

7.Severe pulmonary complications, such as interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema.
8.With Evidence or history of psychiatric disability and central neurological disorder.
9.Diarrhea.
10.Systemic continuous administration of steroid drugs(p.o. or i.v.).
11.Pregnant, woman of child-bearing potential or lactating woman.
12.Not appropriate for the study at the physician's assessment.

Target sample size

130

Name of lead principal investigator

1st name
Middle name
Last name	Hideyuki Ishida

Organization

Saitama Medical Center,Saitama Medical University

Division name

Department of digestive tract and

Zip code

Address

1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN

TEL

048-228-3619

Email

05hishi@saitama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Satomi Oyama

Organization

Saitama Medical Center,Saitama Medical University

Division name

Department of digestive tract and

Zip code

Address

1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN

TEL

048-228-3619

Homepage URL

Email

05hishi@saitama-med.ac.jp

Institute

Saitama Medical Center,Saitama Medical University

Institute

Department

Personal name

Organization

Saitama Medical Center,Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

・埼玉医科大学総合医療センター（埼玉県）
・東松山医師会病院（埼玉県）
・福島県立医科大学病院（福島県）
・獨協医科大学病院（栃木県）
・東京女子医科大学東医療センター（東京都）
・高砂協立病院（東京都）
・帝京大学ちば総合医療センター（千葉県）
・松田病院（静岡県）
・金沢赤十字病院（石川県）
・順天堂大学医学部附属静岡病院（静岡県）
・千葉労災病院（千葉）
・高知大学医学部附属病院がん治療センター（高知）
・東邦大学医療センター佐倉病院（千葉）
・日本医科大学付属病院（東京都）
・友愛記念病院（茨城）
・獨協医科大学越谷病院（埼玉）
・上尾中央総合病院（埼玉）

Date of disclosure of the study information

2011

Year

04

Month

12

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

2010

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

12

Day

Last modified on

2017

Year

04

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005434