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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007901
Receipt No. R000009190
Scientific Title A feasibility study of XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for colorectal cancer. (KSCC1201)
Date of disclosure of the study information 2012/05/07
Last modified on 2017/04/30

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Basic information
Public title A feasibility study of XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for colorectal cancer. (KSCC1201)
Acronym A feasibility study of XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for colorectal cancer. (KSCC1201)
Scientific Title A feasibility study of XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for colorectal cancer. (KSCC1201)
Scientific Title:Acronym A feasibility study of XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for colorectal cancer. (KSCC1201)
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 efficacy and safety of the XELOX plus Ca/Mg and Goshajinkigan as adjuvant chemotherapy for 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 Overall survival
Disease free survival
Safety
Relative dose intensity

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 Oxaliplatin 130mg/m2 i.v. (day1)
Capecitabine2,000mg/m2 ,p.o.(day1-14)
Ca/Mg 0.8-1g/body i.v. x2 before and after L-OHP infusion (day1)
Goshajinkigan 7.5g/body ,p.o.(day1-21)
to be repeated every 3 weeks
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. High risk Stage II/Stage III, histologically confirmed colorectal adenocarcinoma.
4. #Tumor is mainly located in between cecum and upper rectum, excluding appendix.
#Distal border of the tumor is located above the peritoneal reflection.
5.R0 resection was performed.
6. Can register within 8 weeks after surgery.
7.ECOG performance status of 0-1.
8.Aged 20<= years.
9. Adequate organ function. (within 14 days before registration):
- WBC>= 3000 and WBC < 12000/mm3
- Neu >=1,500/mm3
- Plt >= 100,000/mm3
- Hb >= 9.0g/dl
- T-Bil <= 2.0mg/dl
- AST,ALT <= 100IU/L
- Creatinine < 1.5mg/dl
Key exclusion criteria 1.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. Positive for hepatitis B or C virus.
9.Requiring steroid drug.
10.Pregnant or lactating woman.
11.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus, uncontrolled diabetes, liver cirrhosis, kidney failure, uncontrolled hypertension, history of cardiac infarction.
12. Preoperative chemotherapy or radiotherapy.
13.Hypercalcemia ,renal calculus.
14.Requiring cardiac glycoside.
15.Chronic treatment with anti-hypersensitivity drug.
16.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
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
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)
琉球大学(沖縄県)
済生会福岡総合病院(福岡県)
済生会八幡総合病院(福岡県)
製鉄記念八幡病院(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)
久留米大学(福岡県)
宗像医師会病院(福岡県)
田川市立病院(福岡県)
公立学校共済組合九州中央病院(福岡県)
福岡市民病院(福岡県)
長崎大学(長崎県)
佐世保市立総合病院(長崎県)
伊万里・有田地区医療福祉組合 伊万里有田共立病院(佐賀県)
熊本大学(熊本県)
済生会熊本病院(熊本県)
健康保険人吉総合病院(熊本県)
高野会高野病院(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)
九州大学病院別府病院(大分県)
鹿児島大学(鹿児島県)
鹿児島共済会南風病院(鹿児島県)
鹿児島県立薩南病院(鹿児島県)
国立病院機構南九州病院(鹿児島県)
今給黎総合病院(鹿児島県)
済生会川内病院(鹿児島県)
ハートライフ病院(沖縄県)
中頭病院(沖縄県)
豊見城中央病院(沖縄県)
松山赤十字病院(愛媛県)
神戸市立医療センター 中央市民病院(兵庫県)
広島赤十字・原爆病院(広島県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 07 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
2012 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2018 Year 04 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
2012 Year 05 Month 07 Day
Last modified on
2017 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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