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
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
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
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
