UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004884
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m.suenaga@jfcr.or.jp

Sponsor
Institute Japanese foundation for cancer research
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.