UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004884 |
|---|---|
| Receipt number | R000005813 |
| Scientific Title | A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2016/02/16 10:56:44 |
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Basic information
Public title
A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer
Acronym
A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan (RE-OPEN study)
Scientific Title
A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer
Scientific Title:Acronym
A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan (RE-OPEN study)
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of reintroduction of oxaliplatin (FOLFOX) in patients with metastatic colorectal cancer who have failed prior chemotherapy with oxaliplatin and irinotecan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate after 12 weeks of treatment.
Key secondary outcomes
Adverse Effect
Response Rate
Progression-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
mFOLFOX6
5FU bolus: 400 mg/m2 d1
5FU infusion: 2400 mg/m2/46h d1
Oxaliplatin: 85mg/m2 d1
l-LV: 200mg/m2 d1
Q2w
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. Histological confirmation of colorectal cancer.
2. Achieved tumor response (PR or CR) or stable disease (SD) during prior oxaliplatin-based therapy.
3. Six months or over from confirmed progression disease during previous oxaliplatin-based therapy.
4. Treatment history of previous irinotecan-based chemotherapy.
5. Measurable or evaluable disease (RECIST ver.1.1.)
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
7. Age of 20 years or older.
8. Life expectancy greater than or equal to 3 months 12 weeks.
9. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i. Neurtophils > or =1500/mm3
ii. Platelets> or =100,000/mm3
iii. Hemoglobin> or =9.0g/dl
iv. AST and ALT = or <upper limit of normal (ULN)*2.5 (= or <ULN*5 in case of liver metastasis)
v. Total bilirubin = or <upper limit of normal (ULN)*1.5
vi. Serum creatinine = or <upper limit of normal (ULN)*1.5
10. Written informed consent.
Key exclusion criteria
1. Severe peripheral neuropathy.
2. History of the serious hypersensitivity for drugs.
3. Active infection.
4. Complications (Evidence of interstinal lung disease, emphysema, pulmonary fibrosis, paralytic or mechanical bowel obstruction, uncontrolled hypertension, uncontrolled diabetes mellitus, cirrhosis, active cardiovascular disease, or past or current history (within 3 months) of myocardial infarction, uncontrolled angina pectoris or arrythmia.
5. Multiple primary cancer within 5years.
6. Need to drain pleural effusion, ascites or pericardial effusion.
7. Uncontrolled diarrhea.
8. Radiological evidence of brain cancer.
9. Clinically significant mental or psychological disease.
10. Other conditions not suitable for this study.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Mizunuma |
Organization
The cancer institute hospital of JFCR
Division name
Gastroenterological center
Zip code
Address
3-8-31 Ariake Koto-ku Tokyo
TEL
03-3520-0111
mizunuma@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsukuni Suenaga |
Organization
The cancer institute hospital of JFCR
Division name
Gastroenterological center
Zip code
Address
3-8-31 Ariake Koto-ku Tokyo
TEL
03-3520-0111
Homepage URL
m.suenaga@jfcr.or.jp
Sponsor or person
Institute
Japanese foundation for cancer research
Institute
Department
Personal name
Funding Source
Organization
None
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
癌研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005813
