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 UMIN000002182
Receipt No. R000001991
Scientific Title A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Date of disclosure of the study information 2009/07/10
Last modified on 2013/01/10

* 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 to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Acronym A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Scientific Title A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Scientific Title:Acronym A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
Region
Japan

Condition
Condition patients with advanced/recurrent colon cancer who cannot undergo common protocol
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A response and adverse events of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer are evaluated on patients with some disorder who cannot be registered to common protocol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall Response Rate (ORR)
Key secondary outcomes Incidence of Adverse Events, and their grades
Progression-Free Survival (PFS)
Overall Survival (OS)
Incidence of Completion of the regimen

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 l
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) colon cancer diagnosed pathologically
2) primary advanced colon cancer and/or metastatic colon cancer
3) with measurable lesion
4) without any prior chemotherapy or with 180 days period after
postoperative chemotherapy
5) expected more than 3 months survival
6) patients without any severe disorder on bone marrow, lung, liver, or
kidney and satisfies the body conditions
1. Hb >= 9.0g/dL
2. WBC: 4,000 – 12,000/mm3
3. Neutrocyte: >= 1,500mm3
4. platelet: >= 100,000/mm3
5. T bil: <= 1.5 mg/dL
6. AST,ALT: >= 100U/L or 200U/L for patients with liver matastasis
7. sCr: <= 1.2mg/dL
8. CCr: >= 50mL/min
[Cockcroft-Gault]expected=[(140 - age)x body weight]/[72 x sCr]
7) with normal ECG within 28 days
8) IC form written by patient
9) patients who have at least one of these functions
1.Patients cannot be registered to l-OHP/CPT-11 therapy by doctor
2. ECOG PS 1-2
3. age: >= 65 years old
4. sAlb: < 3.5 g/dl

3.prior radiation therapy for pelvic/abdominal lesions
Key exclusion criteria 1) ECOG PS 3-4
2) with brain tumor or brain metastasis
3) with double cancer diagnosed within 5 years except basal cell
Carcinoma, CIS of portio and/or CIS of digestive tract treated
curatively
4) with a symptom of neuro-vascular disorder on the brain
5) without surgical treatment, open biopsy, and/or suturing of injury
6) with plans of surgical operation during this regimen
7) with easy bleeding and/or coagulation disorder
8) with a history of thrombosis
9) with ulcer on digestive tracts which is uncontrollable
10) with an inflammation of abdominal organs
11) with a disorder on the kidney which needs some therapies
12) with an uncontrolled hypertension
13) with an severe allergy against fluorouracil. Levohorinate carcium
14)patients with a lack of emzyme; DPD (dehydropyrimidine dehydrogenase) or with an adverse events due to fluoropyrimidine
15) with an uncontrollable diarrhea
16) with an interstitial pneumonia or pulmonary fibrosis
17) patients who need immuno-suppressive medicines after an organ transplantation
18) with an uncontrollable infection
19) pregnant females, nursing mother or pregnancy test positive females
20) males who do not protect pregnancy
21) patients whom doctor cannot register to this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kato
Organization Mino City Hospital
Division name Dpt.Surgery
Zip code
Address 5-7-1 kasano, Minou City, Osaka 562-8562
TEL 072-728-2001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kato
Organization Mino City Hospital
Division name Dpt.Surgery
Zip code
Address 5-7-1 kasano, Minou City, Osaka 562-8562
TEL 072-728-2001
Homepage URL
Email

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 10 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
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 10 Day
Last modified on
2013 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.