UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003708
Receipt number R000004396
Scientific Title A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer
Date of disclosure of the study information 2010/07/14
Last modified on 2017/04/30 18:26:43

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Basic information

Public title

A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer

Acronym

A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer(KSCC0903)

Scientific Title

A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer

Scientific Title:Acronym

A feasibility study of adjuvant therapy with FOLFOX plus Ca/Mg for the patient with colorectal cancer(KSCC0903)

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of adjuvant treatment with a combination of FOLFOX plus Ca/Mg for the patient with colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

the rate of completion of treatment as planned

Key secondary outcomes

Safety (especially peripheral neuropathy, digestive symptom )
Quality of life
Disease free survival
Overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

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), 5FU2400mg/m2(civ)).
Ca/Mg 0.8-1g (iv) x2 before and after L-OHP infusion
Cycles of therapy are given every 2 weeks for 12 cycles

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Written informed consent
2.Appropriate for the study at the physician's assessment
3.Histologically confirmed adenocarcinoma of the colon or rectum.(the tumor above the peritoneal reflection )(except appendix)
4.Histological high risk StageII and Stage III colorectal adenocarcinoma.
5.Tumor resection with D2orD3 lymph node dissection was performed.
6.Resection of histological curability A was performed
7.Aged 20<= years.
8.ECOG performance status of 0-1.
9.No prior chemotherapy and radiotherapy
10.Recovery of postoperative complications
11.Required baseline laboratory parameters (within 14 days before registration):
WBC more than 3000 and WBC less than 12000/mm3
Neu more than 1,500/mm3
Plt more than 100,000/mm3
Hb more than 9.0g/dl
T-Bil less than 2.0mg/dl
AST,ALT within 2.5 times of normal limit of each hospital
Cre less than 1.5mg/dl
12.Registration within 8 weeks after surgery

Key exclusion criteria

1.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration.
2.History of the severe hypersensitivity.
3.Sensory neuropathy.
4.Active other malignancies.
5.Active infection
6.History of mental disorder,central nerve disorder.
7.Watery stools or Grade 2 or more diarrhea
8.Requiring steroid drug
9.Pregnant or lactating woman
10.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus,uncontrolled diabetes, liver cirrhosis, viral hepatitis type B ,kidney failure, uncontrolled hypertension, history of cardiac infarction
11.History of the internal organ transplant
12.Hypercalcemia ,renal calculus
13.Requiring cardiac glycoside
14.High probability of recurrence
15.Not appropriate for the study at the physician's assessment

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Nishimaki

Organization

University of the Ryukyus Faculty of Medicine

Division name

Department of Surgery Medicine

Zip code


Address

207 Uehara, Nishiharacho, Nakagamigun, Okinawa, 903-0215, Japan

TEL

092-631-2920

Email

kscc2@cres-kyushu.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name KSCC

Organization

Clinical Research Support Center Kyushu

Division name

KSCC

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582

TEL

092-631-2920

Homepage URL


Email

kscc2@cres-kyushu.or.jp


Sponsor or person

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

九州大学(福岡県)
貝塚病院(福岡県)
国立病院機構九州医療センター(福岡県)
公立学校共済組合九州中央病院(福岡県)
済生会福岡総合病院(福岡県)
新日鐵八幡記念病院(福岡県)
国立病院機構福岡東医療センター(福岡県)
社会保険田川病院(福岡県)
社会保険仲原病院(福岡県)
久留米大学(福岡県)
久留米大学医療センター(福岡県)
社会保険久留米第一病院(福岡県)
公立八女総合病院(福岡県)
福岡大学(福岡県)
済生会八幡総合病院(福岡県)
麻生飯塚病院(福岡県)
済生会唐津病院(佐賀県)
健康保険諫早総合病院(長崎県)
佐世保市立総合病院(長崎県)
長崎大学(長崎県)
白十字会 佐世保中央病院(長崎県)
国立病院機構長崎医療センター(長崎県)
春回会 井上病院(長崎県)
光晴会病院(長崎県)
長崎百合野病院(長崎県)
医理会 柿添病院(長崎県)
熊本大学(熊本県)
高野会 高野病院(熊本県)
済生会熊本病院(熊本県)
熊本赤十字病院(熊本県)
熊本中央病院(熊本県)
大分赤十字病院(大分県)
国立病院機構大分医療センター(大分県)  
国立病院機構別府医療センター(大分県)
中津市立中津市民病院(大分県)
大分県立病院(大分県)
潤愛会 鮫島病院(鹿児島県)
鹿児島大学(鹿児島県)
鹿児島厚生連病院(鹿児島県)
鹿児島共済会南風病院(鹿児島県)
済生会川内病院(鹿児島県)
浦添総合病院(沖縄県)
中頭病院(沖縄県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
琉球大学(沖縄県)
北部地区医師会病院(沖縄県)
豊見城中央病院(沖縄県)
ハートライフ病院(沖縄県)
広島赤十字・原爆病院(広島県)
松山赤十字病院(愛媛県)


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 14 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

2010 Year 03 Month 30 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

Other related information



Management information

Registered date

2010 Year 06 Month 04 Day

Last modified on

2017 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004396


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name